GE Healthcare, LLC: Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.

Recall number

Z-1751-2019

Recalling firm

GE Healthcare, LLC

Product

Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.

Status

Terminated

Initiated

2019-03-29

Posted

2019-06-10

Terminated

2021-04-15

Reason

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

Root cause

Device Design

Action

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.

Quantity

825 (38 US and 787 OUS) in total

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K943805"]

PMA numbers

not on file

Product code

JAA

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy