FDA · Medical device recall

GE Vscan Extend… and 6 more products

Feb. 2, 2022 Class II

Date: Feb. 2, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Distribution pattern: Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Ecuador, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Haiti, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Papua New Guinea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sweden, Switzerland, Thailand, Togo, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, and Western Sahara.

7 products in this recall

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Console"
Quantity: 12,526 total reported units (7 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Number)". VH1622261Y (01008406821216511118042621VH1622261Y, 5693455), VH161664XA (01008406821216511118031921VH161664XA, 5693455), VH2627194S (01008406821216511120071321VH2627194S, 5693455), VH160129E8 (01008406821216511117021721VH160129E8, 5693455), VH160834YQ (01008406821216511117110021VH160834YQ, 5693455), VH1642124F (01008406821216511119040921VH1642124F, 5693455), VH150152W7 (01008406821216511116080021VH150152W7, 5693455), VH160113JQ (01008406821216511117020321VH160113JQ, 5693455), VH161979EY (01008406821216511118030021VH161979EY, 5693455), VH162446PC (01008406821216511118061221VH162446PC, 5693455), VH161984GS (01008406821216511118030021VH161984GS, 5693455), VH161970GQ (01008406821216511118030021VH161970G, 5693455), VH1619899S (01008406821216511118030021VH1619899S, 5693455), VH160237FQ (01008406821216511117030021VH160237FQ, 5693455), VH1600005U (5693455), VH160007CX (5693455), VH160009UF (5693455), VH150153FK (5693455), VH161672SF (5693455), VH1624281N (5693455), VH150103AI (5693455), VH150150Z6 (5693455), VH160786JM (5693455), VH1608086P (5693455), VH1600107T (5693455), VH1607384V (5693455), VH1600112G (5693455), VH160012JB (5693455), VH1607406X (5693455), VH160742EX (5693455), VH1608215J (5693455), VH160633NC (5693455), VH160025HU (5693455), VH160744ZM (5693455), VH150151QA (5693455), VH160730NB (5693455), VH161629J2 (5693455), VH161631UU (5693455), VH160735W7 (5693455), VH161598QQ (5693455), VH1600189D (5693455), VH1501544T (5693455), VH160017E2 (5693455), VH150123AH (5693455), VH163240NI (5693455), VH160005HB (5693455), VH1656702Z (5693455), VH16567191 (5693455), VH1656729W (5693455), VH1656736Y (5693455), VH165674RL (5693455), VH165675AQ (5693455), VH165676D7 (5693455), VH1656777R (5693455), VH165678YC (5693455), VH165679H1 (5693455), VH150112VD (5693455), VH150113IF (5693455), VH1607343V (5693455), VH160012JB (5693455), VH150101S2 (5693455), VH160001S1 (5693455), VH160003N9 (5693455), VH1616079K (5693455), VH150105RI (5693455), VH150118BJ (5693455), VH1501144B (5693455), VH150119KV (5693455), VH150122PV (5693455), VH150104JE (5693455), VH150067PS (5693455), VH150102JE (5693455), VH16162756 (5693455), VH260391G7 (5693455), VH2609418F (5693455), VH26096618 (5693455), VH1600301G (5693455), VH160021FJ (5693455), VH160163HW (5693455)
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0518-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Quantity: 12,526 total reported units (9,771 units of this model)
Codes and lots: Information reads "Serial Number (Model Number, Labeling, UDI)". VH162804HB (01008406821216511118070021VH162804HB, H41212ZA), VH261412UX (01008406821216511120040021VH261412UX, H41212ZA), VH261635DJ (01008406821216511120040021VH261635DJ, H41212ZA), VH261660DH (01008406821216511120040021VH261660DH, H41212ZA), VH262868PS (01008406821216511120071721VH262868PS, H41212ZA), VH162941AB (01008406821216511118090021VH162941AB, H41212ZA), VH266179UH (01008406821216511121081721VH266179UH, H41212ZA), VH164477C1 (01008406821216511119050021VH164477C1, H41212ZA), VH262930DV (01008406821216511120071721VH262930DV, H41212ZA), VH260225R9 (01008406821216511119120021VH260225R9, H41212ZA), VH16105885 (01008406821216511117100021VH16105885, H41212RN), VH1618109Q (01008406821216511118020021VH1618109Q, H41212RN), VH1618127M (01008406821216511118020021VH1618127M, H41212RN), VH162786AS (01008406821216511118072521VH162786AS, H41212ZA), VH163954E2 (01008406821216511119031921VH163954E2, H41212ZA), VH160716CP (01008406821216511117070021VH160716CP, H41212RN), VH160368VF (01008406821216511117032221VH160368VF, H41212RN), VH164216AP (01008406821216511119032721VH164216AP, H41212ZA), VH261981MJ (01008406821216511120081121VH261981MJ, H41212ZA), VH264256QP (01008406821216511120121821VH264256QP, H41212ZA), VH2657824M (01008406821216511121062321VH2657824M, H41212ZA), VH265885RM (01008406821216511121071621VH265885RM, H41212ZA), VH162822XP (01008406821216511118070021VH162822XP, H41212ZA), VH160402SS (01008406821216511117042421VH160402SS, H41212RN), VH165093DJ (01008406821216511119062821VH165093DJ, H41212ZA), VH261080RY (01008406821216511120030021VH261080RY, H41212ZA), VH261141GX (01008406821216511120030021VH261141GX, H41212ZA), VH162956I3 (01008406821216511118100021VH162956I3, H41212ZA), VH163189T6 (01008406821216511118100021VH163189T6, H41212ZA), VH2602335E (01008406821216511119120021VH2602335E, H41212ZA), VH260243BG (01008406821216511119120021VH260243BG, H41212ZA), VH260265CX (01008406821216511119120021VH260265CX, H41212ZA), VH162420Z9 (01008406821216511118050021VH162420Z9, H41212ZA), VH162788Z1 (01008406821216511118070021VH162788Z1, H41212ZA), VH265125Z4 (01008406821216511121032621VH265125Z4, H41212ZA), VH2600177X (01008406821216511119120021VH2600177X, H41212ZA), VH1632842M (01008406821216511118100021VH1632842M, H41212ZA), VH164854MH (01008406821216511119060021VH164854MH, H41212ZA), VH164938U3 (01008406821216511119060021VH164938U3, H41212ZA), VH262978UW (01008406821216511120073021VH262978UW, H41212ZA), VH2661816S (01008406821216511121081721VH2661816S, H41212ZA), VH160442KT (01008406821216511117050021VH160442KT, H41212RN), VH262836XX (01008406821216511120071621VH262836XX, H41212ZA), VH16263643 (01008406821216511118070021VH16263643, H41212ZA), VH162877XD (01008406821216511118070021VH162877XD, H41212ZA), VH1628794W (01008406821216511118080021VH1628794W, H41212ZA), VH163026KZ (01008406821216511118100021VH163026KZ, H41212ZA), VH163059LM (01008406821216511118100021VH163059LM, H41212ZA), VH163195M6 (01008406821216511118100021VH163195M6, H41212ZA), VH164636LU (01008406821216511119050021VH164636LU, H41212ZA), VH164657PH (01008406821216511119050021VH164657PH, H41212ZA), VH164708TI (01008406821216511119050021VH164708TI, H41212ZA), VH164721SC (01008406821216511119050021VH164721SC, H41212ZA), VH164740QH (01008406821216511119050021VH164740QH, H41212ZA), VH164748TN (01008406821216511119050021VH164748TN, H41212ZA), VH261627JV (01008406821216511120040021VH261627JV, H41212ZA), VH261687Z8 (01008406821216511120042121VH261687Z8, H41212ZA), VH262874VI (01008406821216511120071621VH262874VI, H41212ZA), VH262941EY (01008406821216511120072221VH262941EY, H41212ZA), VH263062I3 (01008406821216511120080421VH263062I3, H41212ZA), VH263682ER (01008406821216511120110221VH263682ER, H41212ZA), VH264146NR (01008406821216511121020421VH264146NR, H41212ZA), VH264255HC (01008406821216511120121821VH264255HC, H41212ZA), VH264671L1 (01008406821216511121020421VH264671L1, H41212ZA), VH265122D9 (01008406821216511121032621VH265122D9, H41212ZA), VH26546198 (01008406821216511121070521VH26546198, H41212ZA), VH2654891A (01008406821216511121061721VH2654891A, H41212ZA), VH265644PM (01008406821216511121070721VH265644PM, H41212ZA), VH265662TN (01008406821216511121061621VH265662TN, H41212ZA), VH265807VN (01008406821216511121070621VH265807VN, H41212ZA), VH2658316S (01008406821216511121070721VH2658316S, H41212ZA), VH265872PG (01008406821216511121072621VH265872PG, H41212ZA), VH265895LA (01008406821216511121072321VH265895LA, H41212ZA), VH265900VF (01008406821216511121071921VH265900VF, H41212ZA), VH265923UV (01008406821216511121080221VH265923UV, H41212ZA), VH265984RH (01008406821216511121080221VH265984RH, H41212ZA), VH265999UL (01008406821216511121080221VH265999UL, H41212ZA), VH266282UU (01008406821216511121091321VH266282UU, H41212ZA), VH162164RM (01008406821216511118050021VH162164RM, H41212ZA), VH2629271Q (01008406821216511120072921VH2629271Q, H41212ZA), VH263002BW (01008406821216511120072821VH263002BW, H41212ZA), VH160259ML (01008406821216511117031721VH160259ML, H41212RN), VH26390423 (01008406821216511120111921VH26390423, H41212ZA), VH2640245Z (01008406821216511120111921VH2640245Z, H41212ZA), VH1605723D (01008406821216511117050021VH1605723D, H41212RN), VH1607136W (01008406821216511117070021VH1607136W, H41212RN), VH263362AR (01008406821216511120100121VH263362AR, H41212ZA), VH164537C2 (01008406821216511119060021VH164537C2, H41212ZA), VH164361WE (01008406821216511119040021VH164361WE, H41212ZA), VH164365TP (01008406821216511119040021VH164365TP, H41212ZA), VH1643725I (01008406821216511119040021VH1643725I, H41212ZA), VH16438323 (01008406821216511119040021VH16438323, H41212ZA), VH263009XH (01008406821216511120072921VH263009XH, H41212ZA), VH160371ZM (01008406821216511117042021VH160371ZM, H41212RN), VH160401S1 (01008406821216511117040021VH160401S1, H41212RN), VH160431E6 (01008406821216511117040021VH160431E6, H41212RN), VH161103LJ (01008406821216511117100021VH161103LJ, H41212RN), VH163835ZE (01008406821216511119031121VH163835ZE, H41212ZA), VH164489GE (01008406821216511119050021VH164489GE, H41212ZA), VH165207BW (01008406821216511119070021VH165207BW, H41212ZA), VH260123DF (01008406821216511119120021VH260123DF, H41212ZA), VH26018245 (01008406821216511119120021VH26018245, H41212ZA), VH2629182A (01008406821216511120072321VH2629182A, H41212ZA), VH160389HF (01008406821216511117041121VH160389HF, H41212RN), VH161937YM (01008406821216511118030021VH161937YM, H41212RN), VH263542BQ (01008406821216511120111621VH263542BQ, H41212ZA), VH160287QW (01008406821216511117041221VH160287QW, H41212RN), VH164904XF (01008406821216511119060021VH164904XF, H41212ZA), VH160582GQ (01008406821216511117050021VH160582GQ, H41212RN), VH260018V8 (01008406821216511119120021VH260018V8, H41212ZA), VH260043Z3 (01008406821216511119120021VH260043Z3, H41212ZA), VH260045IX (01008406821216511119120021VH260045IX, H41212ZA), VH260070ZS (01008406821216511119120021VH260070ZS, H41212ZA), VH26009138 (01008406821216511119120021VH26009138, H41212ZA), VH262245KL (01008406821216511120061521VH262245KL, H41212ZA), VH265598WP (01008406821216511121070721VH265598WP, H41212ZA), VH265828GY (01008406821216511121070721VH265828GY, H41212ZA), VH162507YA (01008406821216511118060021VH162507YA, H41212ZA), VH16414587 (01008406821216511119030021VH16414587, H41212ZA), VH163109Z5 (01008406821216511118101921VH163109Z5, H41212ZA), VH163303CN (01008406821216511118111221VH163303CN, H41212ZA), VH260816JF (01008406821216511120020021VH260816JF, H41212ZA), VH160313S8 (01008406821216511117032221VH160313S8, H41212RN), VH160029UP (01008406821216511116120021VH160029UP, H41212RN), VH160037EW (01008406821216511116122921VH160037EW, H41212RN), VH160039SM (01008406821216511116120021VH160039SM, H41212RN), VH160043RB (01008406821216511116120021VH160043RB, H41212RN), VH16004513 (01008406821216511117020821VH16004513, H41212RN), VH1600549M (01008406821216511117020121VH1600549M, H41212RN), VH160058I5 (01008406821216511116122921VH160058I5, H41212RN), VH160068ZU (01008406821216511117021721VH160068ZU, H41212RN), VH16007192 (01008406821216511117021321VH16007192, H41212RN), VH160101G5 (01008406821216511117020321VH160101G5, H41212RN), VH160102RJ (01008406821216511117021721VH160102RJ, H41212RN), VH160111V7 (01008406821216511117020221VH160111V7, H41212RN), VH160112LE (01008406821216511117041221VH160112LE, H41212RN), VH160115YH (01008406821216511117020121VH160115YH, H41212RN), VH160116XN (01008406821216511117020221VH160116XN, H41212RN), VH160133Y8 (01008406821216511117020721VH160133Y8, H41212RN), VH160223E9 (01008406821216511117031721VH160223E9, H41212RN), VH160413HB (01008406821216511117040021VH160413HB, H41212RN), VH161714XA (01008406821216511118020021VH161714XA, H41212RN), VH161725UN (01008406821216511118020021VH161725UN, H41212RN), VH1617526R (01008406821216511118020021VH1617526R, H41212RN), VH161766VW (01008406821216511118020021VH161766VW, H41212RN), VH161809XH (01008406821216511118020021VH161809XH, H41212RN), VH162303G8 (01008406821216511118050021VH162303G8, H41212ZA), VH1624534L (01008406821216511118060021VH1624534L, H41212ZA), VH1628007C (01008406821216511118070021VH1628007C, H41212ZA), VH163177DY (01008406821216511118100021VH163177DY, H41212ZA), VH164088K8 (01008406821216511119032721VH164088K8, H41212ZA), VH164592DH (01008406821216511119050021VH164592DH, H41212ZA), VH1646012H (01008406821216511119050021VH1646012H, H41212ZA), VH165279YB (01008406821216511119070021VH165279YB, H41212ZA), VH260830K5 (01008406821216511120020021VH260830K5, H41212ZA), VH260923GB (01008406821216511120020021VH260923GB, H41212ZA), VH160902YQ (01008406821216511118050021VH160902YQ, H41212ZA), VH265863RP (01008406821216511121071621VH265863RP, H41212ZA), VH26003354 (01008406821216511119120021VH26003354, H41212ZA), VH26058792 (01008406821216511120010021VH26058792, H41212ZA), VH1628959W (01008406821216511118070021VH1628959W, H41212ZA), VH1626588P (01008406821216511118070021VH1626588P, H41212ZA), VH163397AE (01008406821216511118110021VH163397AE, H41212ZA), VH164862GG (01008406821216511119060021VH164862GG, H41212ZA), VH16518336 (01008406821216511119071021VH16518336, H41212ZA), VH165104TE (01008406821216511119060021VH165104TE, H41212ZA), VH160829AH (01008406821216511117080021VH160829AH, H41212RN), VH1608303J (01008406821216511117080021VH1608303J, H41212RN), VH2642225E (01008406821216511120121621VH2642225E, H41212ZA), VH16519953 (01008406821216511119070021VH16519953, H41212ZA), VH260826J6 (01008406821216511120020021VH260826J6, H41212ZA), VH260967LD (01008406821216511120020021VH260967LD, H41212ZA), VH2609842V (01008406821216511120020021VH2609842V, H41212ZA), VH261114QM (01008406821216511120020021VH261114QM, H41212ZA), VH161061MW (01008406821216511118010021VH161061MW, H41212RN), VH162472HA (01008406821216511118060021VH162472HA, H41212ZA), VH1624746C (01008406821216511118060021VH1624746C, H41212ZA), VH16205887 (01008406821216511118040021VH16205887, H41212ZA), VH160988AH (01008406821216511117090021VH160988AH, H41212RN), VH2616702V (01008406821216511120042121VH2616702V, H41212ZA), VH160119Y1 (01008406821216511117021721VH160119Y1, H41212RN), VH160528XA (01008406821216511117050021VH160528XA, H41212RN), VH160569WJ (01008406821216511117050021VH160569WJ, H41212RN), VH16428541 (01008406821216511119050021VH16428541, H41212ZA), VH2656764Q (01008406821216511121061121VH2656764Q, H41212ZA), VH162045MU (01008406821216511118040021VH162045MU, H41212ZA), VH1645434U (01008406821216511119050021VH1645434U, H41212ZA), VH160064KK (01008406821216511117021021VH160064KK, H41212RN), VH264023M2 (01008406821216511120111921VH264023M2, H41212ZA), VH160267DW (01008406821216511117031721VH160267DW, H41212RN), VH161075T4 (01008406821216511117100021VH161075T4, H41212RN), VH2617508J (01008406821216511120050521VH2617508J, H41212ZA), VH160055J6 (01008406821216511117020221VH160055J6, H41212RN), VH160079PZ (01008406821216511117020821VH160079PZ, H41212RN), VH160293EJ (01008406821216511117031721VH160293EJ, H41212RN), VH160319KQ…
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0519-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Quantity: 12,526 total reported units (77 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A, H41212RK), VH160398U2 (01008406821216511117040021VH160398U2, H41212RK), VH160910MS (01008406821216511117090021VH160910MS, H41212RK), VH160692PU (01008406821216511117060021VH160692PU, H41212RK), VH16072033 (01008406821216511117060021VH16072033, H41212RK), VH164639E1 (01008406821216511119060021VH164639E1, H41212YY), VH165023E4 (01008406821216511119090021VH165023E4, H41212YY), VH26557563 (01008406821216511121071221VH26557563, H41212YY), VH265583RM (01008406821216511121070921VH265583RM, H41212YY), VH2656017N (01008406821216511121070821VH2656017N, H41212YY), VH265638Q4 (01008406821216511121070921VH265638Q4, H41212YY), VH26564046 (01008406821216511121070921VH26564046, H41212YY), VH265645Q7 (01008406821216511121070821VH265645Q7, H41212YY), VH265647U2 (01008406821216511121070921VH265647U2, H41212YY), VH265836ZG (01008406821216511121071221VH265836ZG, H41212YY), VH265838JV (01008406821216511121071221VH265838JV, H41212YY), VH265842CE (01008406821216511121071221VH265842CE, H41212YY), VH265844SA (01008406821216511121070921VH265844SA, H41212YY), VH265845WV (01008406821216511121071221VH265845WV, H41212YY), VH265849MM (01008406821216511121070921VH265849MM, H41212YY), VH265851HS (01008406821216511121071221VH265851HS, H41212YY), VH26585212 (01008406821216511121070921VH26585212, H41212YY), VH265857ZW (01008406821216511121070921VH265857ZW, H41212YY), VH265858LY (01008406821216511121071221VH265858LY, H41212YY), VH265864P5 (01008406821216511121070921VH265864P5, H41212YY), VH1632681A (01008406821216511118100021VH1632681A, H41212YY), VH160462WV (01008406821216511117040021VH160462WV, H41212RK), VH160549FR (01008406821216511117060021VH160549FR, H41212RK), VH16055357 (01008406821216511117060021VH16055357, H41212RK), VH160673KV (01008406821216511117060021VH160673KV, H41212RK), VH160674YQ (01008406821216511117060021VH160674YQ, H41212RK), VH160717US (01008406821216511117060021VH160717US, H41212RK), VH160724UV (01008406821216511117110021VH160724UV, H41212RK), VH160844BL (01008406821216511117110021VH160844BL, H41212RK), VH160851T5 (01008406821216511117110021VH160851T5, H41212RK), VH160879LS (01008406821216511117090021VH160879LS, H41212RK), VH16090735 (01008406821216511117090021VH16090735, H41212RK), VH160911AW (01008406821216511117090021VH160911AW, H41212RK), VH16092049 (01008406821216511117090021VH16092049, H41212RK), VH160934IF (01008406821216511117090021VH160934IF, H41212RK), VH160940WS (01008406821216511117100021VH160940WS, H41212RK), VH160984TC (01008406821216511117100021VH160984TC, H41212RK), VH161007CG (01008406821216511117100021VH161007CG, H41212RK), VH161008JP (01008406821216511117100021VH161008JP, H41212RK), VH161028CS (01008406821216511117100021VH161028CS, H41212RK), VH1610527V (01008406821216511117100021VH1610527V, H41212RK), VH1610803G (01008406821216511117100021VH1610803G, H41212RK), VH161086VQ (01008406821216511117100021VH161086VQ, H41212RK), VH1610908L (01008406821216511117100021VH1610908L, H41212RK), VH16109229 (01008406821216511117100021VH16109229, H41212RK), VH161231L5 (01008406821216511117110021VH161231L5, H41212RK), VH161675YG (01008406821216511118030021VH161675YG, H41212RK), VH162475JG (01008406821216511118100021VH162475JG, H41212YY), VH162998CK (01008406821216511118100021VH162998CK, H41212YY), VH1630084S (01008406821216511118100021VH1630084S, H41212YY), VH1633236I (01008406821216511118110021VH1633236I, H41212YY), VH16065514 (01008406821216511117050021VH16065514, H41212RK), VH162006EW (01008406821216511118030021VH162006EW, H41212RK), VH165572VH (01008406821216511119080021VH165572VH, H41212YY), VH2631208T (01008406821216511120081721VH2631208T, H41212YY), VH263163KT (01008406821216511120081721VH263163KT, H41212YY), VH263287F8 (01008406821216511120081721VH263287F8, H41212YY), VH262239Y9 (01008406821216511120061221VH262239Y9, H41212YY), VH262110GZ (01008406821216511120060221VH262110GZ, H41212YY), VH262109PN (01008406821216511120060221VH262109PN, H41212YY), VH260405KN (01008406821216511119120021VH260405KN, H41212YY), VH261920X9 (01008406821216511120051821VH261920X9, H41212YY), VH263156PR (01008406821216511120091521VH263156PR, H41212YY), VH262014IC (01008406821216511120060221VH262014IC, H41212YY), VH262086QK (01008406821216511120052921VH262086QK, H41212YY), VH261683Q7 (01008406821216511120052921VH261683Q7, H41212YY), VH262773P1 (01008406821216511120070621VH262773P1, H41212YY), VH265406KA (01008406821216511121051821VH265406KA, H41212YY), VH263551YR (01008406821216511120101321VH263551YR, H41212YY), VH2630353P (01008406821216511120101321VH2630353P, H41212YY), VH263549DB (01008406821216511120101321VH263549DB, H41212YY), VH1632534K (01008406821216511118100021VH1632534K, H41212YY), VH160006DB (01008406821216511116080021VH160006DB, H41212RK), VH160022AZ (01008406821216511116080021VH160022AZ, H41212RK), VH264900CN (01008406821216511121030921VH264900CN, H41212YY), VH264904KF (01008406821216511121030921VH264904KF, H41212YY), VH165707BB (01008406821216511119120021VH165707BB, H41212YY)
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0520-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Quantity: 12,526 total reported units (1,115 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Number)". VH161002TY (01008406821216511117092521VH161002TY, H41212RL), VH161494JD (01008406821216511118011021VH161494JD, H41212RL), VH161911LV (01008406821216511118030021VH161911LV, H41212RL), VH163440GG (01008406821216511118121421VH163440GG, H41212YZ), VH261421ZS (01008406821216511120040021VH261421ZS, H41212YZ), VH162444U2 (01008406821216511118060021VH162444U2, H41212YZ), VH165272MV (01008406821216511119070021VH165272MV, H41212YZ), VH264483KQ (01008406821216511121011921VH264483KQ, H41212YZ), VH261426TR (01008406821216511120040021VH261426TR, H41212YZ), VH260601DD (01008406821216511120030021VH260601DD, H41212YZ), VH260693VL (01008406821216511120030021VH260693VL, H41212YZ), VH261300BX (01008406821216511120030021VH261300BX, H41212YZ), VH262303C1 (01008406821216511120061021VH262303C1, H41212YZ), VH1650459M (01008406821216511119060021VH1650459M, H41212YZ), VH26015148 (01008406821216511119120021VH26015148, H41212YZ), VH260359ZY (01008406821216511120030021VH260359ZY, H41212YZ), VH2605125L (01008406821216511120030021VH2605125L, H41212YZ), VH1617429V (01008406821216511118050021VH1617429V, H41212YZ), VH161794AP (01008406821216511118020021VH161794AP, H41212RL), VH165044C8 (01008406821216511119120021VH165044C8, H41212YZ), VH160828M8 (01008406821216511117080021VH160828M8, H41212RL), VH26143341 (01008406821216511120040021VH26143341, H41212YZ), VH264734WW (01008406821216511121020921VH264734WW, H41212YZ), VH163182CD (01008406821216511118090021VH163182CD, H41212YZ), VH265179EX (01008406821216511121040621VH265179EX, H41212YZ), VH163884HV (01008406821216511119031121VH163884HV, H41212YZ), VH260371WV (01008406821216511119120021VH260371WV, H41212YZ), VH260413XV (01008406821216511119120021VH260413XV, H41212YZ), VH261844IZ (01008406821216511120050521VH261844IZ, H41212YZ), VH1634495A (01008406821216511118110021VH1634495A, H41212YZ), VH265859FV (01008406821216511121071221VH265859FV, H41212YZ), VH266211S7 (01008406821216511121090821VH266211S7, H41212YZ), VH260422R5 (01008406821216511119120021VH260422R5, H41212YZ), VH261855IA (01008406821216511120050521VH261855IA, H41212YZ), VH262511X9 (01008406821216511120062521VH262511X9, H41212YZ), VH162672ZZ (01008406821216511118070021VH162672ZZ, H41212YZ), VH2603199C (01008406821216511120030021VH2603199C, H41212YZ), VH261392QA (01008406821216511120040021VH261392QA, H41212YZ), VH2614246U (01008406821216511120040021VH2614246U, H41212YZ), VH264744WA (01008406821216511121020521VH264744WA, H41212YZ), VH163373TQ (01008406821216511118110021VH163373TQ, H41212YZ), VH161230QP (01008406821216511117110021VH161230QP, H41212RL), VH163520B5 (01008406821216511118120021VH163520B5, H41212YZ), VH163543XL (01008406821216511118120021VH163543XL, H41212YZ), VH260572RJ (01008406821216511120030021VH260572RJ, H41212YZ), VH261820EA (01008406821216511120050521VH261820EA, H41212YZ), VH261451K8 (01008406821216511120040021VH261451K8, H41212YZ), VH261467NC (01008406821216511120040021VH261467NC, H41212YZ), VH261556JT (01008406821216511120040021VH261556JT, H41212YZ), VH1635644D (01008406821216511118120021VH1635644D, H41212YZ), VH163574GX (01008406821216511118120021VH163574GX, H41212YZ), VH163602RD (01008406821216511118120021VH163602RD, H41212YZ), VH165182SZ (01008406821216511119090021VH165182SZ, H41212YZ), VH165549SD (01008406821216511119090021VH165549SD, H41212YZ), VH1635656M (01008406821216511118120021VH1635656M, H41212YZ), VH2610751I (01008406821216511120040021VH2610751I, H41212YZ), VH261332S1 (01008406821216511120040021VH261332S1, H41212YZ), VH265083NK (01008406821216511121040621VH265083NK, H41212YZ), VH265941H1 (01008406821216511121071521VH265941H1, H41212YZ), VH162698PH (01008406821216511118070021VH162698PH, H41212YZ), VH16276523 (01008406821216511118070021VH16276523, H41212YZ), VH261336EQ (01008406821216511120040021VH261336EQ, H41212YZ), VH261388BN (01008406821216511120040021VH261388BN, H41212YZ), VH264603D7 (01008406821216511121020521VH264603D7, H41212YZ), VH262582C9 (01008406821216511120062921VH262582C9, H41212YZ), VH2625993T (01008406821216511120062521VH2625993T, H41212YZ), VH1614977P (01008406821216511118010021VH1614977P, H41212RL), VH161800BC (01008406821216511118020021VH161800BC, H41212RL), VH261513Z4 (01008406821216511120040021VH261513Z4, H41212YZ), VH162215VB (01008406821216511118050021VH162215VB, H41212YZ), VH165048BU (01008406821216511119060021VH165048BU, H41212YZ), VH2638216Q (01008406821216511120121421VH2638216Q, H41212YZ), VH2640834X (01008406821216511120121021VH2640834X, H41212YZ), VH2640875J (01008406821216511120121021VH2640875J, H41212YZ), VH264109NY (01008406821216511120121021VH264109NY, H41212YZ), VH264213B3 (01008406821216511120121421VH264213B3, H41212YZ), VH2642289A (01008406821216511120121421VH2642289A, H41212YZ), VH265978R2 (01008406821216511121080321VH265978R2, H41212YZ), VH266059Z5 (01008406821216511121080321VH266059Z5, H41212YZ), VH266118PA (01008406821216511121081921VH266118PA, H41212YZ), VH266145GN (01008406821216511121081921VH266145GN, H41212YZ), VH266147DX (01008406821216511121081921VH266147DX, H41212YZ), VH160626CG (01008406821216511117060021VH160626CG, H41212RL), VH264881B7 (01008406821216511121021921VH264881B7, H41212YZ), VH16062881 (01008406821216511117050021VH16062881, H41212RL), VH162752KG (01008406821216511118070021VH162752KG, H41212YZ), VH2602947V (01008406821216511119120021VH2602947V, H41212YZ), VH161161X7 (01008406821216511117110021VH161161X7, H41212RL), VH163447AN (01008406821216511118120021VH163447AN, H41212YZ), VH160817U6 (01008406821216511117080021VH160817U6, H41212RL), VH160831DT (01008406821216511117070021VH160831DT, H41212RL), VH161236D7 (01008406821216511118050021VH161236D7, H41212YZ), VH164890QH (01008406821216511119060021VH164890QH, H41212YZ), VH264672NX (01008406821216511121020521VH264672NX, H41212YZ), VH264739C5 (01008406821216511121020521VH264739C5, H41212YZ), VH262626QW (01008406821216511120062621VH262626QW, H41212YZ), VH160641B3 (01008406821216511117060021VH160641B3, H41212RL), VH16125325 (01008406821216511117110021VH16125325, H41212RL), VH16454487 (01008406821216511119060021VH16454487, H41212YZ), VH263611VM (01008406821216511120102621VH263611VM, H41212YZ), VH263614T2 (01008406821216511120102621VH263614T2, H41212YZ), VH261845I4 (01008406821216511120050521VH261845I4, H41212YZ), VH162245M3 (01008406821216511118050021VH162245M3, H41212YZ), VH162018NS (01008406821216511118030021VH162018NS, H41212RL), VH1638115W (01008406821216511119031121VH1638115W, H41212YZ), VH1638201C (01008406821216511119030821VH1638201C, H41212YZ), VH164467LS (01008406821216511119050021VH164467LS, H41212YZ), VH164584CG (01008406821216511119050021VH164584CG, H41212YZ), VH164686DS (01008406821216511119050021VH164686DS, H41212YZ), VH1646922N (01008406821216511119050021VH1646922N, H41212YZ), VH164991MX (01008406821216511119060021VH164991MX, H41212YZ), VH162224CG (01008406821216511118050021VH162224CG, H41212YZ), VH162749BJ (01008406821216511118070021VH162749BJ, H41212YZ), VH262212TX (01008406821216511120061121VH262212TX, H41212YZ), VH161643YV (01008406821216511118020021VH161643YV, H41212RL), VH2617435R (01008406821216511120050521VH2617435R, H41212YZ), VH1648107H (01008406821216511119060021VH1648107H, H41212YZ), VH163786XY (01008406821216511119120021VH163786XY, H41212YZ), VH165541XG (01008406821216511119080021VH165541XG, H41212YZ), VH161516I9 (01008406821216511119012521VH161516I9, H41212YZ), VH1636783E (01008406821216511119012821VH1636783E, H41212YZ), VH161866G9 (01008406821216511118030021VH161866G9, H41212RL), VH16541359 (01008406821216511119100021VH16541359, H41212YZ), VH260052B2 (01008406821216511119120021VH260052B2, H41212YZ), VH260026KJ (01008406821216511119120021VH260026KJ, H41212YZ), VH260047QI (01008406821216511119120021VH260047QI, H41212YZ), VH163412LI (01008406821216511118110021VH163412LI, H41212YZ), VH163438PF (01008406821216511118110021VH163438PF, H41212YZ), VH163500JY (01008406821216511118110021VH163500JY, H41212YZ), VH161470W5 (01008406821216511117120021VH161470W5, H41212RL), VH164984KS (01008406821216511119060021VH164984KS, H41212YZ), VH1656641X (01008406821216511119100021VH1656641X, H41212YZ), VH16172044 (01008406821216511118040021VH16172044, H41212YZ), VH165559GX (01008406821216511119100021VH165559GX, H41212YZ), VH162057DP (01008406821216511118040021VH162057DP, H41212YZ), VH162447EL (01008406821216511118060021VH162447EL, H41212YZ), VH161747Z1 (01008406821216511118030021VH161747Z1, H41212RL), VH2632989P (01008406821216511120091621VH2632989P, H41212YZ), VH262858C4 (01008406821216511120072221VH262858C4, H41212YZ), VH263047XC (01008406821216511120072221VH263047XC, H41212YZ), VH263049P4 (01008406821216511120072121VH263049P4, H41212YZ), VH263059W2 (01008406821216511120091421VH263059W2, H41212YZ), VH263061TK (01008406821216511120091421VH263061TK, H41212YZ), VH263069TP (01008406821216511120091421VH263069TP, H41212YZ), VH263073XA (01008406821216511120091421VH263073XA, H41212YZ), VH263165IW (01008406821216511120091421VH263165IW, H41212YZ), VH263168B2 (01008406821216511120091421VH263168B2, H41212YZ), VH263179XG (01008406821216511120091421VH263179XG, H41212YZ), VH265273Z5 (01008406821216511121040821VH265273Z5, H41212YZ), VH262913G4 (01008406821216511120072221VH262913G4, H41212YZ), VH262345MR (01008406821216511120081021VH262345MR, H41212YZ), VH263208EJ (01008406821216511120091621VH263208EJ, H41212YZ), VH261795SU (01008406821216511120081021VH261795SU, H41212YZ), VH263041WS (01008406821216511120072221VH263041WS, H41212YZ), VH262925TH (01008406821216511120072221VH262925TH, H41212YZ), VH2632014E (01008406821216511120091621VH2632014E, H41212YZ), VH262841C2 (01008406821216511120071521VH262841C2, H41212YZ), VH263038NU (01008406821216511120072221VH263038NU, H41212YZ), VH263182MJ (01008406821216511120091421VH263182MJ, H41212YZ), VH26319736 (01008406821216511120091821VH26319736, H41212YZ), VH263282K8 (01008406821216511120091621VH263282K8, H41212YZ), VH263303AD (01008406821216511120091821VH263303AD, H41212YZ), VH2632068F (01008406821216511120091821VH2632068F, H41212YZ), VH263274SC (01008406821216511120091821VH263274SC, H41212YZ), VH262902SW (01008406821216511120072221VH262902SW, H41212YZ), VH262042EA (01008406821216511120081021VH262042EA, H41212YZ), VH26288286 (01008406821216511120072121VH26288286, H41212YZ), VH263263U3 (01008406821216511120091821VH263263U3, H41212YZ), VH262155JZ (01008406821216511120081021VH262155JZ, H41212YZ), VH262237E5 (01008406821216511120081021VH262237E5, H41212YZ), VH262834VN (01008406821216511120072221VH262834VN, H41212YZ), VH262899XJ (01008406821216511120072221VH262899XJ, H41212YZ), VH2629369Y (01008406821216511120072221VH2629369Y, H41212YZ), VH261748II (01008406821216511120081021VH261748II, H41212YZ), VH2619377H (01008406821216511120081021VH2619377H, H41212YZ), VH2629164T (01008406821216511120072221VH2629164T, H41212YZ), VH263107E3 (01008406821216511120091621VH263107E3, H41212YZ), VH263159P9 (01008406821216511120091621VH263159P9, H41212YZ), VH26318617 (01008406821216511120091821VH26318617, H41212YZ), VH263304C4 (01008406821216511120091821VH263304C4, H41212YZ), VH263305Z5 (01008406821216511120091621VH263305Z5, H41212YZ), VH261927WJ (01008406821216511120081021VH261927WJ, H41212YZ), VH262806W7 (01008406821216511120081021VH262806W7, H41212YZ), VH265350PU (01008406821216511121042921VH265350PU, H41212YZ), VH265362ZF (01008406821216511121042921VH265362ZF, H41212YZ), VH2654383P (01008406821216511121043021VH2654383P, H41212YZ), VH2654429T (01008406821216511121042921VH2654429T, H41212YZ), VH265477JM (01008406821216511121043021VH265477JM, H41212YZ), VH265531Y7 (01008406821216511121042921VH265531Y7, H41212YZ), VH265547CH (01008406821216511121043021VH265547CH, H41212YZ), VH265539ZP (01008406821216511121042921VH265539ZP, H41212YZ), VH160992G3 (01008406821216511117100021VH160992G3, H41212RL), VH161510VE (01008406821216511117120021VH161510VE, H41212RL), VH164186UT (01008406821216511119032521VH164186UT, H41212YZ), VH163066UJ (01008406821216511118110021VH163066UJ, H41212YZ), VH163527ZC (01008406821216511118110021VH163527ZC…
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0521-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Quantity: 12,526 total reported units (1,451 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Number)". VH200176M2 (01008406821216511120080721VH200176M2, H41212ZD), VH150224FV (01008406821216511117040421VH150224FV, H41212RT), VH150359UT (01008406821216511118020021VH150359UT, H41212RT), VH150510JG (01008406821216511118110021VH150510JG, H41212ZD), VH150725FX (01008406821216511119031521VH150725FX, H41212ZD), VH150726PL (01008406821216511119031521VH150726PL, H41212ZD), VH150833LB (01008406821216511119050021VH150833LB, H41212ZD), VH2004729L (01008406821216511120122221VH2004729L, H41212ZD), VH200602E1 (01008406821216511121031021VH200602E1, H41212ZD), VH2007327J (01008406821216511121062921VH2007327J, H41212ZD), VH1504296K (01008406821216511118070021VH1504296K, H41212ZD), VH2001141J (01008406821216511120010021VH2001141J, H41212ZD), VH200727M4 (01008406821216511121061421VH200727M4, H41212ZD), VH200416DE (01008406821216511120111221VH200416DE, H41212ZD), VH1505184H (01008406821216511118120021VH1505184H, H41212ZD), VH200022GP (01008406821216511119120021VH200022GP, H41212ZD), VH150208XB (01008406821216511117040421VH150208XB, H41212RT), VH200663IW (01008406821216511121061521VH200663IW, H41212ZD), VH2006663X (01008406821216511121061521VH2006663X, H41212ZD), VH20071415 (01008406821216511121061721VH20071415, H41212ZD), VH200719LG (01008406821216511121061521VH200719LG, H41212ZD), VH150488AN (01008406821216511118110021VH150488AN, H41212ZD), VH200092VS (01008406821216511120010021VH200092VS, H41212ZD), VH200158ZR (01008406821216511120020021VH200158ZR, H41212ZD), VH20078872 (01008406821216511121072321VH20078872, H41212ZD), VH150329VP (01008406821216511118021321VH150329VP, H41212RT), VH200042EG (01008406821216511119120021VH200042EG, H41212ZD), VH1501645D (01008406821216511117052321VH1501645D, H41212RT), VH20049973 (01008406821216511120122221VH20049973, H41212ZD), VH150627JD (01008406821216511119012121VH150627JD, H41212ZD), VH1510213I (01008406821216511119110021VH1510213I, H41212ZD), VH200078CB (01008406821216511119120021VH200078CB, H41212ZD), VH200086VZ (01008406821216511120010021VH200086VZ, H41212ZD), VH200104JD (01008406821216511120030021VH200104JD, H41212ZD), VH2001402U (01008406821216511120020021VH2001402U, H41212ZD), VH200604XJ (01008406821216511121022421VH200604XJ, H41212ZD), VH20076953 (01008406821216511121072221VH20076953, H41212ZD), VH200772N5 (01008406821216511121072221VH200772N5, H41212ZD), VH150304YL (01008406821216511118020221VH150304YL, H41212RT), VH1504811P (01008406821216511118102221VH1504811P, H41212ZD), VH150483QI (01008406821216511118110121VH150483QI, H41212ZD), VH150486BT (01008406821216511118110121VH150486BT, H41212ZD), VH150487IA (01008406821216511118110421VH150487IA, H41212ZD), VH150717E8 (01008406821216511119031321VH150717E8, H41212ZD), VH150524EK (01008406821216511118120021VH150524EK, H41212ZD), VH150814W4 (01008406821216511119050021VH150814W4, H41212ZD), VH150815EB (01008406821216511119050021VH150815EB, H41212ZD), VH1508226B (01008406821216511119050021VH1508226B, H41212ZD), VH1508233A (01008406821216511119050021VH1508233A, H41212ZD), VH1509599D (01008406821216511119060021VH1509599D, H41212ZD), VH200035ND (01008406821216511119120021VH200035ND, H41212ZD), VH200439SJ (01008406821216511120120921VH200439SJ, H41212ZD), VH200668T6 (01008406821216511121061521VH200668T6, H41212ZD), VH200681YL (01008406821216511121061421VH200681YL, H41212ZD), VH2007231C (01008406821216511121061421VH2007231C, H41212ZD), VH200724YY (01008406821216511121061521VH200724YY, H41212ZD), VH200820FQ (01008406821216511121091721VH200820FQ, H41212ZD), VH150631WK (01008406821216511119030021VH150631WK, H41212ZD), VH1506566S (01008406821216511119030021VH1506566S, H41212ZD), VH150666EB (01008406821216511119030021VH150666EB, H41212ZD), VH150694FG (01008406821216511119030021VH150694FG, H41212ZD), VH150705HV (01008406821216511119030021VH150705HV, H41212ZD), VH1503974U (01008406821216511118050021VH1503974U, H41212ZD), VH15096421 (01008406821216511119070021VH15096421, H41212ZD), VH200777KC (01008406821216511121081621VH200777KC, H41212ZD), VH150852UQ (01008406821216511119050021VH150852UQ, H41212ZD), VH150933LR (01008406821216511119060021VH150933LR, H41212ZD), VH20014163 (01008406821216511120020021VH20014163, H41212ZD), VH200246AI (01008406821216511120070621VH200246AI, H41212ZD), VH200661SQ (01008406821216511121061521VH200661SQ, H41212ZD), VH150770V9 (01008406821216511119032621VH150770V9, H41212ZD), VH150685RS (01008406821216511119031521VH150685RS, H41212ZD), VH200643IQ (01008406821216511121030921VH200643IQ, H41212ZD), VH150197TZ (01008406821216511117041021VH150197TZ, H41212RT), VH150556H5 (01008406821216511118120021VH150556H5, H41212ZD), VH1502025B (01008406821216511117041021VH1502025B, H41212RT), VH150463BS (01008406821216511119012521VH150463BS, H41212ZD), VH150476N7 (01008406821216511118100021VH150476N7, H41212ZD), VH150478M9 (01008406821216511118100021VH150478M9, H41212ZD), VH15049949 (01008406821216511118110021VH15049949, H41212ZD), VH150939CY (01008406821216511119060021VH150939CY, H41212ZD), VH150966FW (01008406821216511119070021VH150966FW, H41212ZD), VH151009GP (01008406821216511119070021VH151009GP, H41212ZD), VH15095159 (01008406821216511119060021VH15095159, H41212ZD), VH200554DE (01008406821216511121021521VH200554DE, H41212ZD), VH200629YK (01008406821216511121042321VH200629YK, H41212ZD), VH200687HZ (01008406821216511121050521VH200687HZ, H41212ZD), VH2005171B (01008406821216511121050521VH2005171B, H41212ZD), VH150534ZK (01008406821216511118120021VH150534ZK, H41212ZD), VH2000181Y (01008406821216511119120021VH2000181Y, H41212ZD), VH2007173Q (01008406821216511121061721VH2007173Q, H41212ZD), VH200217M7 (01008406821216511120070321VH200217M7, H41212ZD), VH200510IG (01008406821216511121012121VH200510IG, H41212ZD), VH150593J7 (01008406821216511118120021VH150593J7, H41212ZD), VH1504548H (01008406821216511118100021VH1504548H, H41212ZD), VH1504715C (01008406821216511118100021VH1504715C, H41212ZD), VH150474WN (01008406821216511118100021VH150474WN, H41212ZD), VH200731XE (01008406821216511121072321VH200731XE, H41212ZD), VH150716UE (01008406821216511119031321VH150716UE, H41212ZD), VH150979SP (01008406821216511119070021VH150979SP, H41212ZD), VH150946J9 (01008406821216511119060021VH150946J9, H41212ZD), VH1504906N (01008406821216511118110021VH1504906N, H41212ZD), VH150492LE (01008406821216511118110021VH150492LE, H41212ZD), VH1506025B (01008406821216511118120021VH1506025B, H41212ZD), VH200720QV (01008406821216511121081621VH200720QV, H41212ZD), VH2007679J (01008406821216511121072221VH2007679J, H41212ZD), VH150665RD (01008406821216511119030021VH150665RD, H41212ZD), VH200252LK (01008406821216511120070321VH200252LK, H41212ZD), VH1506738G (01008406821216511119031421VH1506738G, H41212ZD), VH150689PY (01008406821216511119031421VH150689PY, H41212ZD), VH1504385A (01008406821216511118070021VH1504385A, H41212ZD), VH150596YR (01008406821216511118120021VH150596YR, H41212ZD), VH150960VF (01008406821216511119060021VH150960VF, H41212ZD), VH150254NQ (01008406821216511117050021VH150254NQ, H41212RT), VH1502283P (01008406821216511117050021VH1502283P, H41212RT), VH1502317W (01008406821216511117050021VH1502317W, H41212RT), VH200107AS (01008406821216511120010021VH200107AS, H41212ZD), VH20075119 (01008406821216511121072321VH20075119, H41212ZD), VH200752M2 (01008406821216511121072621VH200752M2, H41212ZD), VH200275M7 (01008406821216511120090221VH200275M7, H41212ZD), VH150227ER (01008406821216511117050021VH150227ER, H41212RT), VH150189QS (01008406821216511117033021VH150189QS, H41212RT), VH150212R5 (01008406821216511117041021VH150212R5, H41212RT), VH150561QF (01008406821216511118120021VH150561QF, H41212ZD), VH150567D8 (01008406821216511118120021VH150567D8, H41212ZD), VH20054963 (01008406821216511121021221VH20054963, H41212ZD), VH1503401Y (01008406821216511118020021VH1503401Y, H41212RT), VH2005224E (01008406821216511121012221VH2005224E, H41212ZD), VH2005588V (01008406821216511121012221VH2005588V, H41212ZD), VH200591PJ (01008406821216511121021921VH200591PJ, H41212ZD), VH2005503I (01008406821216511121012621VH2005503I, H41212ZD), VH2000053R (01008406821216511119120021VH2000053R, H41212ZD), VH200146I4 (01008406821216511120020021VH200146I4, H41212ZD), VH200152FN (01008406821216511120020021VH200152FN, H41212ZD), VH151022CU (01008406821216511119110021VH151022CU, H41212ZD), VH150237AU (01008406821216511117040021VH150237AU, H41212RT), VH200027XC (01008406821216511119120021VH200027XC, H41212ZD), VH200131Y4 (01008406821216511120010021VH200131Y4, H41212ZD), VH150615B5 (01008406821216511119050021VH150615B5, H41212ZD), VH150688AN (01008406821216511119030021VH150688AN, H41212ZD), VH150758Z5 (01008406821216511119030021VH150758Z5, H41212ZD), VH150862WP (01008406821216511119050021VH150862WP, H41212ZD), VH1508832G (01008406821216511119050021VH1508832G, H41212ZD), VH200471ZZ (01008406821216511120122121VH200471ZZ, H41212ZD), VH200105YC (01008406821216511120010021VH200105YC, H41212ZD), VH2001089D (01008406821216511120010021VH2001089D, H41212ZD), VH200261H3 (01008406821216511120081021VH200261H3, H41212ZD), VH150963DG (01008406821216511119070021VH150963DG, H41212ZD), VH200021JN (01008406821216511119120021VH200021JN, H41212ZD), VH200026HU (01008406821216511119120021VH200026HU, H41212ZD), VH2000996T (01008406821216511120010021VH2000996T, H41212ZD), VH200101LN (01008406821216511120010021VH200101LN, H41212ZD), VH150404MV (01008406821216511118040021VH150404MV, H41212ZD), VH150571WK (01008406821216511118120021VH150571WK, H41212ZD), VH200113YM (01008406821216511120020021VH200113YM, H41212ZD), VH200115M1 (01008406821216511120020021VH200115M1, H41212ZD), VH2001366M (01008406821216511120020021VH2001366M, H41212ZD), VH150493R8 (01008406821216511118110021VH150493R8, H41212ZD), VH150494LS (01008406821216511118110021VH150494LS, H41212ZD), VH150531CH (01008406821216511118120021VH150531CH, H41212ZD), VH200020RX (01008406821216511119120021VH200020RX, H41212ZD), VH200218C9 (01008406821216511120071521VH200218C9, H41212ZD), VH15091369 (01008406821216511119060021VH15091369, H41212ZD), VH1508477J (01008406821216511119050021VH1508477J, H41212ZD), VH150926JN (01008406821216511119060021VH150926JN, H41212ZD), VH150956RY (01008406821216511119070021VH150956RY, H41212ZD), VH200654NL (01008406821216511121030821VH200654NL, H41212ZD), VH15067725 (01008406821216511119030021VH15067725, H41212ZD), VH150981U9 (01008406821216511119070021VH150981U9, H41212ZD), VH20007584 (01008406821216511120030021VH20007584, H41212ZD), VH150230FP (01008406821216511117050021VH150230FP, H41212RT), VH150555GV (01008406821216511118120021VH150555GV, H41212ZD), VH200249XM (01008406821216511120070321VH200249XM, H41212ZD), VH1505176H (01008406821216511118120021VH1505176H, H41212ZD), VH2001798W (01008406821216511120080721VH2001798W, H41212ZD), VH150854YW (01008406821216511119050021VH150854YW, H41212ZD), VH150875TJ (01008406821216511119050021VH150875TJ, H41212ZD), VH200199CN (01008406821216511120080721VH200199CN, H41212ZD), VH1501804M (01008406821216511117033021VH1501804M, H41212RT), VH150190A1 (01008406821216511117033021VH150190A1, H41212RT), VH150209MN (01008406821216511117041021VH150209MN, H41212RT), VH150361DW (01008406821216511118020021VH150361DW, H41212RT), VH150901PH (01008406821216511119060021VH150901PH, H41212ZD), VH150994HJ (01008406821216511119070021VH150994HJ, H41212ZD), VH1506937W (01008406821216511119030021VH1506937W, H41212ZD), VH200653AF (01008406821216511121032621VH200653AF, H41212ZD), VH200279JY (01008406821216511120081421VH200279JY, H41212ZD), VH200300WP (01008406821216511120081421VH200300WP, H41212ZD), VH150444LD (01008406821216511118090021VH150444LD, H41212ZD), VH20000386 (01008406821216511119120021VH20000386, H41212ZD), VH200025VK (01008406821216511119120021VH200025VK, H41212ZD), VH200721P4 (01008406821216511121061421VH200721P4, H41212ZD), VH150343MC (01008406821216511118020021VH150343MC, H41212RT), VH150177RI (01008406821216511117033021VH150177RI, H41212RT), VH150608HG (01008406821216511118120021VH150608HG, H41212ZD), VH150906E7 (01008406821216511119060021VH150906E7…
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0522-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Quantity: 12,526 total reported units (61 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Number)". VH150315TI (01008406821216511118020021VH150315TI, H41212RR), VH15019235 (01008406821216511117033021VH15019235, H41212RR), VH150328FJ (01008406821216511118021321VH150328FJ, H41212RR), VH1503146U (01008406821216511118020921VH1503146U, H41212RR), VH1503356H (01008406821216511118021321VH1503356H, H41212RR), VH150318PI (01008406821216511118020821VH150318PI, H41212RR), VH2006357M (01008406821216511121031721VH2006357M, H41212ZB), VH1505402S (01008406821216511118120021VH1505402S, H41212ZB), VH150277MA (01008406821216511117100021VH150277MA, H41212RR), VH150278XK (01008406821216511119030221VH150278XK, H41212ZB), VH150280EN (01008406821216511117100021VH150280EN, H41212RR), VH15028191 (01008406821216511117100021VH15028191, H41212RR), VH150282CY (01008406821216511117100021VH150282CY, H41212RR), VH150283L3 (01008406821216511117100021VH150283L3, H41212RR), VH150296YP (01008406821216511118010021VH150296YP, H41212RR), VH150298DQ (01008406821216511118010021VH150298DQ, H41212RR), VH150299RZ (01008406821216511118010021VH150299RZ, H41212RR), VH15030049 (01008406821216511118010021VH15030049, H41212RR), VH150301JU (01008406821216511118010021VH150301JU, H41212RR), VH150305E7 (01008406821216511118020021VH150305E7, H41212RR), VH150325R6 (01008406821216511118020021VH150325R6, H41212RR), VH150332EL (01008406821216511118020021VH150332EL, H41212RR), VH150334AV (01008406821216511118020021VH150334AV, H41212RR), VH150356RI (01008406821216511118020021VH150356RI, H41212RR), VH150369TF (01008406821216511118020021VH150369TF, H41212RR), VH150396VW (01008406821216511118050021VH150396VW, H41212ZB), VH150398X2 (01008406821216511118050021VH150398X2, H41212ZB), VH1504078Q (01008406821216511118060021VH1504078Q, H41212ZB), VH150413SH (01008406821216511118060021VH150413SH, H41212ZB), VH1504145M (01008406821216511118060021VH1504145M, H41212ZB), VH150418YP (01008406821216511118060021VH150418YP, H41212ZB), VH15041959 (01008406821216511118110021VH15041959, H41212ZB), VH150498S4 (01008406821216511118110021VH150498S4, H41212ZB), VH1505015I (01008406821216511118110021VH1505015I, H41212ZB), VH1505026L (01008406821216511118110021VH1505026L, H41212ZB), VH150503FG (01008406821216511118110021VH150503FG, H41212ZB), VH150504PC (01008406821216511118110021VH150504PC, H41212ZB), VH150505WS (01008406821216511118110021VH150505WS, H41212ZB), VH150541JB (01008406821216511118120021VH150541JB, H41212ZB), VH150599H5 (01008406821216511119010021VH150599H5, H41212ZB), VH150603Q1 (01008406821216511119010021VH150603Q1, H41212ZB), VH1506321L (01008406821216511119030421VH1506321L, H41212ZB), VH150635LI (01008406821216511119030421VH150635LI, H41212ZB), VH150667SK (01008406821216511119040321VH150667SK, H41212ZB), VH150672TF (01008406821216511119040021VH150672TF, H41212ZB), VH150787F1 (01008406821216511119040021VH150787F1, H41212ZB), VH150788JE (01008406821216511119040021VH150788JE, H41212ZB), VH1503213I (01008406821216511118020021VH1503213I, H41212RR), VH150804V1 (01008406821216511119040021VH150804V1, H41212ZB), VH1506815J (01008406821216511119040021VH1506815J, H41212ZB), VH150409WM (01008406821216511118060021VH150409WM, H41212ZB), VH150753TC (01008406821216511119040421VH150753TC, H41212ZB), VH150421I5 (01008406821216511118080021VH150421I5, H41212ZB), VH200797WX (01008406821216511121090221VH200797WX, H41212ZB), VH150766CY (01008406821216511119050021VH150766CY, H41212ZB), VH20076196 (01008406821216511121090221VH20076196, H41212ZB), VH150520G8 (01008406821216511118120021VH150520G8, H41212ZB), VH2003248W (01008406821216511120091621VH2003248W, H41212ZB), VH150614LJ (01008406821216511119010021VH150614LJ, H41212ZB), VH1508428Q (01008406821216511119050021VH1508428Q, H41212ZB), VH200338JV (01008406821216511120091621VH200338JV, H41212ZB), VH1501821N (01008406821216511117030021VH1501821N, H41212RR), VH200729TM (01008406821216511121080521VH200729TM, H41212ZB)
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0523-2022

GE Vscan Extend…

Product: GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Quantity: 12,526 total reported units (44 units of this model)
Codes and lots: Information reads "Serial Number (UDI, Model Number)". VH200223DX (01008406821216511120100821VH200223DX, H41212ZD), VH150287BJ (01008406821216511118010021VH150287BJ, H41212RS), VH200066HU (01008406821216511119120021VH200066HU, H41212ZD), VH200162ER (01008406821216511120071621VH200162ER, H41212ZC), VH20016794 (01008406821216511120071521VH20016794, H41212ZC), VH150601D6 (01008406821216511119011821VH150601D6, H41212ZC), VH200230XX (01008406821216511120071621VH200230XX, H41212ZC), VH200169VK (01008406821216511120071521VH200169VK, H41212ZC), VH200237TC (01008406821216511120071621VH200237TC, H41212ZC), VH200132U6 (01008406821216511120010021VH200132U6, H41212ZC), VH150275W5 (01008406821216511117090021VH150275W5, H41212RS), VH1504669B (01008406821216511118110021VH1504669B, H41212ZC), VH1508481L (01008406821216511119090021VH1508481L, H41212ZC), VH150284N3 (01008406821216511117100021VH150284N3, H41212RS), VH150265SH (01008406821216511117070021VH150265SH, H41212RS), VH1502694X (01008406821216511117070021VH1502694X, H41212RS), VH150433TG (01008406821216511118110021VH150433TG, H41212ZC), VH150968IT (01008406821216511119070021VH150968IT, H41212ZC), VH200286ZF (01008406821216511120082121VH200286ZF, H41212ZC), VH15036053 (01008406821216511118030021VH15036053, H41212RS), VH1503587A (01008406821216511118030021VH1503587A, H41212RS), VH150958Z4 (01008406821216511119060021VH150958Z4, H41212ZC), VH1502743H (01008406821216511117080021VH1502743H, H41212RS), VH150221EE (01008406821216511117090621VH150221EE, H41212RS), VH150909SW (01008406821216511119060021VH150909SW, H41212ZC), VH1509252J (01008406821216511119060021VH1509252J, H41212ZC), VH150620EN (01008406821216511119060021VH150620EN, H41212ZC), VH150902EF (01008406821216511119060021VH150902EF, H41212ZC), VH1509347X (01008406821216511119060021VH1509347X, H41212ZC), VH15083871 (01008406821216511119050021VH15083871, H41212ZC), VH150839JY (01008406821216511119050021VH150839JY, H41212ZC), VH15075671 (01008406821216511119032121VH15075671, H41212ZC), VH150736AR (01008406821216511119032021VH150736AR, H41212ZC), VH150657SF (01008406821216511119030721VH150657SF, H41212ZC), VH150388NZ (01008406821216511118050021VH150388NZ, H41212ZC), VH150617DA (01008406821216511118120021VH150617DA, H41212ZC), VH1503194P (01008406821216511118040021VH1503194P, H41212ZC), VH200346QM (01008406821216511120100821VH200346QM, H41212ZC), VH2003445A (01008406821216511120100821VH2003445A, H41212ZC), VH150610SB (01008406821216511119010021VH150610SB, H41212ZC), VH150289ZR (01008406821216511118010021VH150289ZR, H41212RS), VH150819MK (01008406821216511119050021VH150819MK, H41212ZC), VH150529PP (01008406821216511118120021VH150529PP, H41212ZC), VH150606XW (01008406821216511119090021VH150606XW, H41212ZC), VH1505755D (01008406821216511118120021VH1505755D, H41212ZC), VH150747UN (01008406821216511119032621VH150747UN, H41212ZC), VH200165ZC (01008406821216511120071421VH200165ZC, H41212ZC), VH200170IX (01008406821216511120071521VH200170IX, H41212ZC), VH200228SY (01008406821216511120071521VH200228SY, H41212ZC), VH200239FZ (01008406821216511120071621VH200239FZ, H41212ZC), VH200163VU (01008406821216511120071621VH200163VU, H41212ZC), VH150695BV (01008406821216511119032121VH150695BV, H41212ZC), VH150708AA (01008406821216511119032121VH150708AA, H41212ZC), VH150745T5 (01008406821216511119032121VH150745T5, H41212ZC), VH150754YW (01008406821216511119032121VH150754YW, H41212ZC), VH150286IC (01008406821216511118010021VH150286IC, H41212RS)
Recall started: Nov. 4, 2021
Device type: System, Imaging, Pulsed Echo, Ultrasonic
Root cause (FDA): Device Design
What the company told customers: The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0524-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0518-2022, Z-0519-2022, Z-0520-2022, Z-0521-2022, Z-0522-2022, Z-0523-2022, Z-0524-2022. The agency record governs; check it and the company before acting.

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