GE Healthcare, LLC recalls Prestige II, Prestige SI, Prestige VH Prestige system is

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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.