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Recall Observatory FDA recall evidence

Device product

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

Z-1751-2019

March 29, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 82668
Status
Terminated
Classification
Class II
Quantity
825 (38 US and 787 OUS) in total
Official record key
device-enforcement:Z-1751-2019

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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