Prestige II recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

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

Recalling firm

GE Healthcare, LLC

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.

Recall date

June 19, 2019

Classification

Class II

Status

Terminated

Agency

FDA (device)