PlainRecordsFDA · Medical device recall
Prestige II… and 4 more products
- Date
- June 19, 2019
- 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
- There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- Distribution pattern
- Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
5 products in this recall
Prestige II…
- Product
- Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
- Quantity
- 825 (38 US and 787 OUS) in total
- Codes and lots
- Prestige II 030133RX32; 080053RX11; 080083RX17; 082408010027; 082408030060A; 082408040021; 082408040036; 082408040037; 082408040044; 082408040045; 082408040047; 082408040048; 082408060005; 082408080006; 082408100070; 082408120030; 082408120032; 082408120033; 082408120037; 082408160055; 082408160056; 082408190006; 082408210030; 082408270027; 0850080431; 0850080628; 0850080701; 0853080153; 0859080008; 209524GR2; 209577PRES; 24646PRESTIGE; 306766BRF2; 3347934R4; 3641PRESTIGE; 388008783XRMET; 38808761XRMET; 38808793XRAND; 38808793XRAND; 38842588XRMET; 38875194XRMET; 38875194XROCC; 3888773XRMET; 38894987XRCTR; 4813MPH; 48660; 519767REM; 519843REM; 540332RM7XXXXX; 60001PRESHM; 600126RX02; 705567VH; 705848REM; 757827RM6; 773854PREST; 84917; 84929; 89763; 902863AREM2; 905871REM; A5371104; A5753801; B5363103; BG4029RX03; BR48660; CS1019RX01; CS1156RX04; DZ1061RX01; EG1251RX01; HC5651XR04; M1828910; M4144612; M4163020; M4198029; M4484605; M5505607; M6042402; PL1507RX01; PPR31321; RU1152RX01; RU1884RX01; SA1231RX03; and X6004701. Prestige SI 2473; 010028RX09; 030024RX13; 030057RX09; 030115RX05; 030309RX08; 030309RX09; 030392RX04; 030488RX01; 040158RX02; 0530863PRE; 06004FLU03; 080100RX04; 080100RX05; 082408050009; 0850080345; 0853080139; 100800RX01; 110018RX05; 160015RX01; 190800RX01; 203573RAD7; 306359ARF1; 38821595XRMET; 38824949XRSOR; 38839875XRSOR; 412343F1; 412343F2; 504380LP2; 506357RF1; 506648RM12A; 514263PRESTIGE; 558039PRESTXT; 600036RX01; 615791W2; 707546XRAY2; 722015002; 808599PRESSI; 902428CRM3349A; 905895RM2; 909580PRESTIGE; 920051; 960025RX01; A1082408; A1111504; A1248010; A1265010; A1300409; A1350106; A1420001; A1532607; A1558706; A1586508; A1586513; A1599005; A1662507; A1767009; A1795401; A1898509; A1962801; A2032101; A2035102; A2072101; A2759005; A2788801; A5109204; A5131828; A5143004; A5145912; A5155124; A5156906; A5186206; A5196319; A5197202; A5216505; A5221505; A5238508; A5269712; A5270003; A5290803; A5323803; A5324803; A5330901; A5354602; A5356913; A5356917; A5358101; A5389206; A5395703; A5396001; A5397405; A5400801; A5400902; A5401303; A5419502; A5637603; A5674401; A5727602; A5807111; A5811711; A5811808; A5814112; A5814401; A6007701; A6014906; A6022104; A6035911; A6038301; A6039707; A6047607; A9884911; A9884912; AP3408XR07; AP4502XR06; B1098609; B1111504; B1222409; B1265010; B1303706; B1485001; B1500413; B1852311; B1989906; B2405502; B2485208; B5115215; B5119102; B5125307; B5127223; B5144909; B5174302; B5174303; B5174304; B5346201; B5374209; B5810209; B6047606; B98689601; BA4001RX01; BA4014RX01; C1074204; C1265006; C1282404; C1607006; C1737601; C5119102; C5129901; C9862608; CE268642; CI1040RX01; CY1010RX01; D1502404; D1598808; D1648601; D4185515; D4185521; DEF99605; DP418833; DPN25102; DPN28001; DPN29001; DZ1014RX01; DZ1024RX01; E1680813; E5821402; EG1070RX01; EG1101RX01; F1669601; FEG60900; FPG22203; GP178304; H13061RF06; H2053RF07; H2197RF05; H2197RF06; J9546503; K1680801; LB1064RX03; LB1065RX01; M1011301; M1013607; M1022102; M1025510; M1033510; M1039405; M1041605; M1074204; M1076846; M1096508; M1098609; M1111504; M1118409; M1137308; M1143415; M1143910; M1192102; M1198105; M1214310; M1225208; M1276501; M1329202; M1388607; M1413612; M1455828; M1469807; M1478607; M1480502; M1522002; M1528409; M1532306; M1558705; M1596410; M1599216; M1625914; M1631806; M1634011; M1653809; M1662008; M1700914; M1711501; M1750209; M1760309; M177858605; M1790301; M1803405; M1806510; M1843404; M1890305; M1962812; M2004601; M2005916; M2050503; M2148216; M2184403; M220648601; M2228001; M224352303; M2324822; M2326003; M2521008; M2565202; M2569117; M2620201; M2624211; M2634202; M2635601; M2718125; M2844616; M2845211; M2845606; M2845611; M2845701; M2864108; M2978303; M4012002; M4020525; M4031057; M4035208; M4041509; M4047511; M4160103; M4172407; M4188810; M4190721; M4209911; M4265604; M4400706; M4460813; M4480505; M4481305; M4485913; M4491604; M4494703; M4548517; M4548519; M470416402; M4859008; M5480805; M5485805; M6001908; M6005406; M6006101; M6012910; M6021006; M6023801; M6024901; M6035913; M6039701; M6042507; M6046306; M6058808; M62631501; M66000404; M9171010; M9792805; MA1219RX01; NC1003RX01; PER09204; PF1017RX02; PL1113RX01; PPR11604; PPR15304; PPR40803; PPR64613; RU1021RX04; RU1032RX02; RU1076RX01; RU1332RX01; RU1591RX02; RU2296RX01; RU2380RX01; RU2417RX01; RU2433RX01; RU2450RX01; RU2460RX01; RU2461RX01; RU2498RX01; RU2592RX01; RU2658RX01; TN1007RX02; TN1009RX02; TN1027RX01; TN1045RX01; TN1055RX02; TN1063RX01; TN1064RX01; TN1072RX01; TN1113RX01; TN1192XR01; TN1211RX01; TN1241RX01; TN1242RX01; TN2001RX02; UK5025RX02; X103911801; X116483805; X128275410; X382885701; X626315001; YP158307; and YP607003. Prestige VH 1773; 00107FLU02; 00336FLU02; 00532FLU03; 010028RX11; 030133RX28; 030137RX08; 030220RX10;080076RX01; 080100RX13; 0853080148; 0853080152; 160012RX03; 190282RX11; 190905RX01; 306359BRF1; 30869; 318473RD3; 38897739XRMET; 418659PRESTIGE; 421PRESTIGE; 536692PRESTIGE; 55085PRESTIGE; 600001RX01; 724284R3; 75648PREST; 808599PRESVH; 819523PRESTIGE; 819879PRESTIGE; 852626PRESTIGE; 860646RF3; 902496REM; 902567PRESTIGE; A1041408; A1279206; A1737608; A1969506; A4463304; A5145724; A5203304; A5216811; A5216812; A5216813; A5216814; A5389610; A5401508; A5414301; A5416101; A5684502; A5811413; A6014902; A6033503; A6064710; A9190111; A9222217; B1039601; B1081908; B1680807; B1720210; B4195715; B5111113; B5266904; B5806715; B5811414; B9185602; B9185603; BG4557RX02; C1248003; C1790301; C1929402; CE673215; CE755A08; D4185519; D5195608; D9956808; DE641212; DE669613; DEG27403; DPM88102; E1484007; EG1039RX04; EG1060RX02; EG1205RX01; EG1214RX01; F5119108; FE416035; FE443837; FEC28A09; FP182A08; FPF64404; FPG26601; FPG30509; FPG44301; FPG58804; G5119101; GP1046RX06; H2036RF14; H2077VAS06; H4858958; K4858901; LB1045RX01; M1013504; M1013608; M1152607; M1185409; M1185412; M1282411; M1622804; M1658910; M1680808; M1796317; M1974117; M1997006; M2742217; M2755002; M2802745; M2802755; M4030501; M4031082; M4159445; M4162211; M4162718; M4175810; M4189606; M4191021; M4192006; M4195701; M4196906; M4205406; M4207303; M4209920; M4210233; M4210424; M4210507; M4398206; M4401013; M4464618; M4474709; M4476119; M4477112; M4482788; M4495709; M4500708; M4501203; M4515907; M5460623; M5484813; M6016708; M6018604; M6049211; M6053304; M9865703; ME244360; ME246208; ME667519; ME799809; MP239201; N4192923; NE655313; NO1108RX01; NPV20503; P4172815; P4172816; P4200408; PER51102; PL1096RX01; PL1636RX01; R4211467; R4211473; RU1032RX05; RU1318RX02; RU1457RX01; RU1467RX01; RU1704RX02; RU1944RX01; RU2154RX01; SA1049RX05; SA1050RX05; SA1159RX02; TN1015RX01; TN1118RX01; TN1122RX01; UK1034RX03; UP644104; X62005701; XE0007; XE0018; XE0019; XE0021; XE0022; and XE0024.
- Recall started
- March 29, 2019
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Device Design
- What the company told customers
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1751-2019
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon…
- Product
- Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
- Quantity
- 825 (38 US and 787 OUS) in total
- Codes and lots
- 651789WDR1 and PL1005RX03
- Recall started
- March 29, 2019
- Device type
- System, X-Ray, Stationary
- Root cause (FDA)
- Device Design
- What the company told customers
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1752-2019
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system…
- Product
- Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
- Quantity
- 825 (38 US and 787 OUS) in total
- Codes and lots
- 010120RX03; 030024RX09; 030047RX02; 030077RX01; 030083RX09; 030106RX09; 030236RX01; 030259RX02; 030557RX01; 040059RX04; 040092RX01; 040200RX04; 0779; 080083RX11; 110018RX01; 12916PREST; 130015RX03; 130136RX01; 130156RX01; 13517PREST; 160113RX01; 160163RX02; 18410PREST; 190052RX05;190083RX01; 200023RX01; 220117RX03; 250142; 306694RF1; 330016; 38132PREST16; 540009; 62442; 73113PTX16; 880001; 918744JF24; 932031001; 95634; 96408; A1092508; A1098606; A1187501; A1411504; A1588501; A1588509; A1607005; A1876201; A1876207; A1898508; A2326001; A4463308; A5118521; A5167917; A5167918; A5170718; A5190924; A5298404; A5306801; A5309805; A5326901; A5487203; A5526302; A5580605; A5604818; A5802707; A5803502; A5810809; A5816105; A5816604; A6014503; AH5205XR01; AH7412XR02; B1249603; B1737601; B5804408; B5811903; C1607003; C1661404; C1669608; C1692202; C9222107; C9956806; CC1498XR01; CEZ08001; D1242801; DE649909; DPE73910; DZ1041RX01; E4644006; EE672818; F2485201; FE387802; FEG48312; GF1009RX02; GP1030RX01; HU1006RX01; LB1001RX01; M1001901; M1035102; M1053501; M1054509; M1074303; M1076827; M1122201; M1130909; M1142502; M1198104; M1199106; M1249606; M1299803; M1313401; M1385401; M1399101; M1413609; M1416106; M1429108; M1435107; M1455808; M1477106; M1492702; M1501904; M1578905; M1584606; M1758601; M1796306; M1919206; M2271506; M2324818; M2324903; M2364507; M2425202; M2503018; M2616710; M2616713; M2842312; M2847101; M2864106; M4031051; M4033051; M4037046; M4472903; M4496205; M4499502; M4503501; M6024001; M6025606; M6025607; M6036204; M6069007; M6076801; M7405602; M9200405; M9409524; M9708009; M9866204; M9868002; M9886619; MA1002RX01; MA1014RX02; MPX35402; NEV12301; NP384101; P6006301; PC0088XR01; PC0490XR01; PER09100; PF1002RX01; PMR25200; PP7281XR02; SK1008RX01; TN1002RX01; TN1006RX01; TN1010RX01; TN1040RX01; TN1044RX01; X88000101; and YE626907.
- Recall started
- March 29, 2019
- Device type
- Table, Radiologic
- Root cause (FDA)
- Device Design
- What the company told customers
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1753-2019
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging…
- Product
- Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
- Quantity
- 825 (38 US and 787 OUS) in total
- Codes and lots
- 204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.
- Recall started
- March 29, 2019
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Device Design
- What the company told customers
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1754-2019
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum…
- Product
- Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
- Quantity
- 825 (38 US and 787 OUS) in total
- Codes and lots
- DZ1061RX02 and UP389014.
- Recall started
- March 29, 2019
- Device type
- System, X-Ray, Stationary
- Root cause (FDA)
- Device Design
- What the company told customers
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1755-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1751-2019, Z-1752-2019, Z-1753-2019, Z-1754-2019, Z-1755-2019. The agency record governs; check it and the company before acting.