FDA · Medical device recall

Discovery IQ 2.0 20cm… and 9 more products

Aug. 8, 2018 Class II

Date: Aug. 8, 2018
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
Distribution pattern: Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

10 products in this recall

Discovery IQ 2.0 20cm…

Product: Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 devices total
Codes and lots: Model Number 5432539-22. Serial Number 502674HM5 (System ID Number 510204DISCIQ); Serial Number 504305HM4 (System ID Number 219922PTIQ)
Recall started: May 24, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2578-2018

Discovery MI Digital Ready

Product: Discovery MI Digital Ready
Reason: DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Model Number 5986030. a. Serial Number PTDMI1800003PT, System ID Number RADNETPT1839, UDI Number 01008406821209751118010421PTDMI1800003PT; b. Serial Number PTDMI1800005PT, System ID Number RADNETPT1838, UDI Number 01008406821209751118010421PTDMI1800003PT; c. Serial Number PTDMI1800009PT, System ID Number 813745DMIDR2, UDI Number 01008406821209751118021921PTDMI1800009PT
Recall started: May 24, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2579-2018

Discovery MI…

Product: Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Model Number 5454001-170. Serial Number (System ID Number): CJRPX1800016CN ( 4550966PT11), CJRPX1800017CN (561422MI), CJRPX1800018CN (617726PET1EB), CJRPX1800021CN (404616DMI)
Recall started: May 24, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2580-2018

Discovery RT labeled as: a…

Product: Discovery RT labeled as: a. MID BJG; b. HVY BJG
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Model Number 2374682-17. a. MID BJG. Serial Number CBCIG1800017HM (System ID 847695CTRT, UDI 01008406821186991118020021CBCIG1800017HM), Serial Number CBCIG1700070HM (System ID 251665MCIRT, UDI 01008406821186991117120021CBCIG1700070HM), Serial Number CBCIG1700064HM (System ID 973831RT, UDI 01008406821186991117120021CBCIG1700064HM), Serial Number CBCIG1800001HM (System ID 708747RT590, UDI 01008406821186991118010021CBCIG1800001HM); b. HVY BJG. Serial Number CBCIG1700062HM (System ID 904819RTCT, UDI 01008406821186991117120021CBCIG1700062HM), Serial Number CBCIG1700040HM (System ID 843692GSOCT, UDI 01008406821186991117100021CBCIG1700040HM)
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2581-2018

Revolution CT 160 1.5D STD WAUK

Product: Revolution CT 160 1.5D STD WAUK
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Model Number 5590000-6. Serial number REVVX1800021CN (System ID 812842REV, UDI 01008406821185521118020021REVVX1800021CN), Serial Number REVVX1800004CN (System ID 269375REVOCT, UDI 01008406821185521118010021REVVX1800004CN).
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2582-2018

CT Goldseal Optima CT 600

Product: CT Goldseal Optima CT 600
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Serial Number 51941YC3, System ID Number 406434660
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2583-2018

Revolution EVO 3.6…

Product: Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: a. HVY WAUK, Serial Number CJRBX1700130CN (System ID 770836EVO, UDI 01008406821097961117120021CJRBX1700130CN), Serial Number CJRBX1800005CN (System ID 918635REVO, UDI 01008406821097961118010021CJRBX1800005CN); b. LONG HINO, Serial Number RE36A1800042YC (System ID 864560REV1, UDI 01008406821097961118020021RE36A1800042YC), Serial Number RE36A1800036YC (System ID 216448REVO, UDI 01008406821097961118020021RE36A1800036YC); c. LONG WAUK, Serial Number CJRBX1800037CN (System ID 740383REVO, UDI 01008406821097961118040021CJRBX1800037CN), Serial Number CJRBX1800022CN (System ID 317415REVO, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CJRBX1800013CN (System ID 423844REVO, UDI 01008406821097961118010021CJRBX1800013CN), Serial Number CJRBX1700132CN (System ID 719557REVO, UDI 01008406821097961117120021CJRBX1700132CN), Serial Number CJRBX1800008CN (System ID 510248EVOCT, UDI 01008406821097961118010021CJRBX1800008CN); d. MID BJG, Serial Number 500918HM8 (System ID 918623REVO, UDI Not Available), Serial Number CBCGG1700116HM (System ID 704834EVO, UDI 01008406821097961117120021CBCGG1700116HM), Serial Number CJRBX1800022CN (System ID 864560REVOL, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CBCGG1700097HM (System ID 979BRENCT1, UDI 01008406821097961117110021CBCGG1700097HM), Serial Number CBCGG1700094HM (System ID 405779REVO, UDI 01008406821097961117110021CBCGG1700094HM), Serial Number CBCGG1700107HM (System ID 217283HREVO, UDI 01008406821097961117110021CBCGG1700107HM), Serial Number CBCGG1700102HM (System ID 303SWDEVO, UDI 01008406821097961117110021CBCGG1700102HM), Serial Number CBCGG1700112HM (System ID 908788EVO, UDI 01008406821097961117120021CBCGG1700112HM), Serial Number 490670HM7 (System ID 718226REVO, UDI Not Available); e. MID WAUK, Serial Number CJRBX1800017CN (System ID 478454EVO, UDI 01008406821097961118020021CJRBX1800017CN), Serial Number CJRBX1800028CN (System ID 210MASHREVO, UDI 01008406821097961118030021CJRBX1800028CN), Serial Number CJRBX1800014CN (System ID 601968REVO, UDI 01008406821097961118010021CJRBX1800014CN).
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2584-2018

Optima CT 520

Product: Optima CT 520
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Serial number, CBCRG1700051HM, System ID Number 580622O520, UDI Number 01008406821025681117120021CBCRG1700051HM
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2585-2018

Optima CT 540

Product: Optima CT 540
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Serial number 500925HM3, System ID Number 615320OPT
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2586-2018

CT Goldseal BrightSpeed 16 PWR TIO 2 YR

Product: CT Goldseal BrightSpeed 16 PWR TIO 2 YR
Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Quantity: 42 units total
Codes and lots: Serial number 194800HM9, System ID Number ALLIANCECT171
Recall started: May 24, 2018
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component change control
What the company told customers: GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Recall number: Z-2587-2018

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

Source: FDA · Medical device enforcement reports, recall numbers Z-2578-2018, Z-2579-2018, Z-2580-2018, Z-2581-2018, Z-2582-2018, Z-2583-2018, Z-2584-2018, Z-2585-2018 and others. The agency record governs; check it and the company before acting.

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