Summary
The FDA issued a Class II for B105M Patient Monitor, REF 6160000-003 by GE Medical Systems, LLC. Reason: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value.
Details
Source
Device Recall
External ID
Z-0731-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
B105M Patient Monitor, REF 6160000-003
Lot/Code Info: UDI/DI 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR622092005WA, SR622092028WA, SR622092001WA, SR622092007WA, SR622092027WA, SR622092010WA, SR622092024WA, SR622092022WA, SR622092006WA, SR622092020WA, SR622092030WA, SR622092013WA, SR622092019WA, SR622092009WA, SR622092016WA, SR622092018WA, SR622092023WA, SR622092032WA, SR622092029WA, SR622092033WA, SR622092015WA, SR622092008WA, SR622092031WA, SR622092011WA, SR622092002WA, SR622092026WA, SR622092003WA, SR622092034WA, SR622092014WA, SR622092021WA, SR622092017WA, SR622092004WA, SR622092035WA, SR622092025WA, SR622360008SA, SR622360009SA, SR622360001SA, SR622360010SA, SR622360006SA, SR622360003SA, SR622360004SA, SR622360002SA, SR622360005SA, SR622360007SA; Model Number 6160000-003-01034677, Serial Numbers: SR622322001WA, SR622322002WA, SR622322003WA, SR622322004WA, SR622322005WA, SR622322006WA, SR622322007WA, SR622322008WA, SR622322009WA, SR622322010WA, SR622322011WA, SR622322012WA, SR622322013WA, SR622322014WA, SR622322015WA; Model Number 6160000-003-01036673, Serial Numbers: SR622362004WA, SR622362001WA, SR622362002WA, SR622362003WA, SR622362005WA, SR622362006WA, SR622362007WA; Model Number 6160000-003-01045082, Serial Numbers: SR622360071SA, SR622360068SA, SR622360069SA, SR622360070SA, SR622360072SA, SR622360033SA, SR622360030SA, SR622360031SA, SR622360032SA, SR622360034SA, SR622360035SA, SR622360036SA, SR622360037SA, SR622360038SA, SR622360039SA, SR622360040SA, SR622360041SA, SR622360042SA, SR622360043SA, SR622360044SA, SR622360045SA, SR622360046SA, SR622360047SA, SR622360048SA, SR622360049SA, SR622360050SA, SR622360051SA, SR622360052SA, SR622360053SA, SR622360054SA, SR622360058SA, SR622360059SA, SR622360060SA, SR622360061SA, SR622360062SA, SR622360063SA, SR622360064SA, SR622360065SA, SR622360067SA, SR622360066SA; Model Number 6160000-003-01047272, Serial Numbers: SR622362012WA, SR622362009WA, SR622362010WA, SR622362011WA, SR622362013WA; Model Number 6160000-003-01054632, Serial Numbers: SR622322041WA, SR622322040WA; Model Number 6160000-003-01054644, Serial Numbers: SR622362019WA, SR622362022WA; Model Number 6160000-003-01054806, Serial Numbers: SR622362020WA, SR622362021WA; Model Number 6160000-003-01056201, Serial Numbers: SR622372110WA, SR622372111WA, SR622372112WA; Model Number 6160000-003-01058032, Serial Numbers: SR622362008WA; Model Number 6160000-003-01058330, Serial Numbers: SR622322032WA, SR622322033WA, SR622322034WA, SR622322035WA; Model Number 6160000-003-01059142, Serial Numbers: SR622362075WA; Model Number 6160000-003-01060133, Serial Numbers: SR622372087WA, SR622372088WA, SR622372089WA, SR622372090WA, SR622372091WA, SR622372092WA; Model Number 6160000-003-01062599, Serial Numbers: SR622372027WA; Model Number 6160000-003-01079753, Serial Numbers: SR622360025SA, SR622360022SA, SR622360023SA, SR622360024SA, SR622360026SA, SR622360027SA, SR622360014SA, SR622360011SA, SR622360012SA, SR622360013SA, SR622360015SA, SR622360016SA, SR622360017SA, SR622360018SA, SR622360019SA, SR622360020SA, SR622360021SA; Model Number 6160000-003-01086095, Serial Numbers: SR622370001SA; Model Number 6160000-003-100174, Serial Numbers: SR622152004WA, SR622152001WA, SR622152002WA, SR622152003WA, SR622152005WA, SR622152006WA, SR622152007WA, SR622152008WA, SR622152009WA, SR622152010WA, SR622152011WA, SR622152012WA, SR622152013WA, SR622152014WA, SR622152015WA, SR622152020WA, SR622152016WA, SR622152017WA, SR622152018WA, SR622152019WA; Model Number 6160000-003-100318, Serial Numbers: SR622192037WA, SR622192036WA; Model Number 6160000-003-100392, Serial Numbers: SR622192031WA; Model Number 6160000-003-100536, Serial Numbers: SR622192002WA, SR622192001WA; Model Number 6160000-003-100708, Serial Numbers: SR622192034WA; Model Number 6160000-003-100729, Serial Numbers: SR622361044PA, SR622361045PA, SR622361046PA, SR622361047PA, SR622361048PA, SR622241039PA, SR622241040PA, SR622361007PA, SR622361003PA, SR622361004PA, SR622361005PA, SR622361008PA, SR622361006PA, SR622361039PA, SR622361042PA, SR622361043PA, SR622381014PA, SR622261004PA, SR622261002PA, SR622261003PA, SR622261005PA, SR622261006PA, SR622261008PA, SR622261010PA, SR622261011PA, SR622261012PA, SR622261001PA, SR622241005PA, SR622241006PA, SR622251005PA, SR622251006PA, SR622251004PA, SR622251002PA, SR622241041PA, SR622241042PA, SR622241043PA, SR622251007PA, SR622251008PA, SR622251003PA, SR622361012PA, SR622361013PA, SR622361014PA, SR622361017PA, SR622361018PA, SR622361015PA, SR622361016PA, SR622361020PA, SR622361021PA, SR622361022PA, SR622361029PA, SR622361030PA, SR622361031PA, SR622361051PA, SR622361052PA, SR622361053PA, SR622361054PA, SR622381007PA, SR622311003PA, SR622381003PA, SR622381006PA, SR622381008PA, SR622381012PA, SR622381009PA, SR622381010PA, SR622381011PA, SR622381013PA, SR622361024PA, SR622361025PA, SR622261009PA, SR622251029PA, SR622251030PA, SR622251031PA, SR622251032PA, SR622261007PA, SR622261033PA, SR622261034PA, SR622261035PA, SR622251024PA, SR622261036PA, SR622251021PA, SR622251020PA, SR622251025PA, SR622251026PA, SR622251027PA, SR622251028PA, SR622251022PA, SR622251023PA, SR622251045PA, SR622251050PA, SR622251051PA, SR622251052PA, SR622251046PA, SR622251048PA, SR622251049PA, SR622311002PA, SR622251047PA, SR622241004PA, SR622251017PA, SR622361010PA, SR622361049PA, SR622361033PA, SR622361034PA, SR622361036PA, SR622361038PA, SR622361032PA, SR622361019PA, SR622361027PA, SR622361028PA, SR622361035PA, SR622361037PA, SR622361023PA, SR622251015PA, SR622241003PA, SR622251013PA, SR622251016PA, SR622241035PA, SR622241033PA, SR622241029PA, SR622241028PA, SR622241030PA, SR622241031PA, SR622241032PA, SR622241034PA, SR622241037PA, SR622241036PA, SR622241038PA, SR622241008PA, SR622241010PA, SR622241011PA, SR622241012PA, SR622241013PA, SR622241014PA, SR622241015PA, SR622241027PA, SR622241026PA, SR622241021PA, SR622241024PA, SR622361026PA, SR622361050PA, SR622251014PA, SR622251011PA, SR622251010PA, SR622251009PA, SR622251019PA, SR622241007PA, SR622361011PA, SR622241009PA, SR622361009PA, SR622241016PA, SR622241017PA, SR622241018PA, SR622241023PA, SR622251018PA, SR622241019PA, SR622241020PA, SR622241025PA; Model Number 6160000-003-100767, Serial Numbers: SR622362290WA, SR622362287WA, SR622362288WA, SR622362289WA, SR622362291WA, SR622362292WA, SR622362293WA, SR622362294WA, SR622362295WA, SR622362296WA, SR622362297WA, SR622362298WA, SR622362299WA, SR622362300WA, SR622362301WA; Model Number 6160000-003-101032, Serial Numbers: SR622342011WA, SR622342012WA, SR622342013WA, SR622342014WA, SR622342015WA, SR622342043WA, SR622342044WA, SR622342045WA, SR622342046WA, SR622342047WA, SR622342048WA, SR622342049WA, SR622342050WA, SR622342051WA, SR622342052WA, SR622342053WA, SR622342054WA, SR622342055WA, SR622342056WA, SR622342057WA, SR622342058WA, SR622342059WA, SR622342060WA, SR622342061WA, SR622342062WA; Model Number 6160000-003-101186, Serial Numbers: SR622372001WA, SR622372002WA, SR622372003WA, SR622372004WA, SR622372005WA, SR622372006WA, SR622372007WA, SR622372008WA, SR622372009WA, SR622372010WA, SR622372012WA, SR622372013WA, SR622372014WA, SR622372015WA, SR622372016WA, SR622372017WA, SR622372018WA, SR622372019WA, SR622372020WA, SR622372021WA, SR622372022WA, SR622372023WA, SR622372024WA, SR622372025WA, SR622372026WA, SR622382018WA, SR622382019WA, SR622382020WA, SR622382021WA, SR622382022WA, SR622382023WA, SR622382024WA, SR622382025WA, SR622382026WA, SR622382027WA; Model Number 6160000-003-101526, Serial Numbers: SR622192027WA, SR622352250WA, SR622352251WA, SR622352252WA, SR622192028WA, SR622192029WA, SR622192026WA, SR622192012WA, SR622192013WA, SR622192014WA; Model Number 6160000-003-101926, Serial Numbers: SR622362024WA, SR622362025WA, SR622362026WA; Model Number 6160000-003-102243, Serial Numbers: SR622352043WA, SR622352044WA, SR622352272WA; Model Number 6160000-003-102677, Serial Numbers: SR622372093WA, SR622372094WA, SR622372095WA, SR622372096WA, SR622372097WA, SR622372098WA, SR622372099WA, SR622372100WA, SR622372101WA, SR622372102WA, SR622372103WA, SR622372104WA, SR622372105WA, SR622372106WA, SR622372107WA, SR622372108WA, SR622372109WA; Model Number 6160000-003-704369, Serial Numbers: SR620510001WA, SR620510003WA; Model Number 6160000-003-704801, Serial Numbers: SR620490014WA, SR620490015WA, SR620490016WA, SR620490017WA, SR620490018WA; Model Number 6160000-003-704821, Serial Numbers: SR620510002WA; Model Number 6160000-003-705415, Serial Numbers: SR621050003WA, SR620510005WA, SR620510006WA; Model Number 6160000-003-708126, Serial Numbers: SR620490012WA, SR620490013WA, SR620520004WA, SR620520001WA, SR620520002WA, SR620520003WA, SR620520005WA, SR620520009WA, SR620520010WA, SR620520011WA, SR620520012WA, SR620520006WA, SR620520007WA, SR620520008WA, SR620520024WA, SR621110053WA, SR621110056WA, SR621110047WA, SR621110049WA, SR621110050WA, SR621110052WA, SR621110054WA, SR621110055WA, SR621110057WA, SR621110058WA, SR620520013WA, SR620520014WA, SR620520019WA, SR620520042WA, SR621010001WA, SR621110020WA, SR621110024WA, SR621110022WA, SR621110023WA, SR621110025WA, SR621110026WA, SR621110027WA, SR621110028WA, SR621110029WA, SR621110021WA, SR621110031WA, SR621010005WA, SR620520038WA, SR620490009WA, SR620520025WA, SR621010003WA, SR621010004WA, SR620520037WA, SR620520039WA, SR620520036WA, SR620520026WA, SR620520027WA, SR620520028WA, SR620520029WA, SR620520030WA, SR620520031WA, SR620520032WA, SR620520033WA, SR620520034WA, SR620520035WA, SR621110043WA, SR620490006WA, SR620520016WA, SR620520017WA, SR620520018WA, SR621110040WA, SR621110041WA, SR621110042WA, SR620520015WA, SR621110018WA, SR621110015WA, SR621110016WA, SR621110017WA, SR621110019WA, SR621110011WA, SR621110012WA, SR621110013WA, SR621110014WA, SR620520040WA, SR620520041WA, SR620490002WA, SR620490010WA, SR620490011WA, SR621110044WA, SR621110045WA, SR621110046WA, SR621110048WA, SR621110051WA, SR620470001WA, SR620470002WA, SR621110030WA, SR621010002WA, SR620520020WA, SR621110038WA, SR621110039WA, SR620490001WA, SR620490003WA, SR620490004WA, SR620490005WA, SR621110032WA, SR621110035WA, SR621110036WA, SR621110037WA, SR621110033WA, SR621110034WA, SR620470004WA, SR620470003WA, SR620470005WA; Model Number 6160000-003-711316, Serial Numbers: SR621010006WA, SR620490019WA, SR620490020WA, SR620490021WA, SR621010009WA, SR621010010WA, SR621010011WA, SR621010012WA, SR621010014WA, SR621010007WA, SR621010008WA, SR621010013WA, SR621010015WA; Model Number 6160000-003-725905, Serial Numbers: SR620510008WA, SR621010017WA, SR621010018WA, SR621010016WA, SR621010019WA, SR620510007WA; Model Number 6160000-003-732539, Serial Numbers: SR621020001WA, SR621040001WA, SR621040002WA, SR621040003WA, SR621040004WA; Model Number 6160000-003-751658, Serial Numbers: SR621040007WA, SR621040005WA, SR621040006WA; Model Number 6160000-003-754973, Serial Numbers: SR621070001WA, SR621070002WA, SR621070003WA, SR621070004WA; Model Number 6160000-003-759088, Serial Numbers: SR621110010WA, SR621110009WA; Model Number 6160000-003-762270, Serial Numbers: SR621050004WA, SR621050005WA; Model Number 6160000-003-762969, Serial Numbers: SR621060001WA, SR621060002WA, SR621060003WA; Model Number 6160000-003-773426, Serial Numbers: SR621080001WA; Model Number 6160000-003-777774, Serial Numbers: SR621070006WA; Model Number 6160000-003-778824, Serial Numbers: SR621100001WA, SR621100002WA, SR621100003WA, SR621100004WA, SR621100005WA, SR621100006WA, SR621100007WA, SR621100008WA, SR621100009WA, SR621100010WA, SR621100011WA, SR621100012WA, SR621100013WA, SR621100014WA, SR621100015WA, SR621100016WA, SR621100017WA, SR621100018WA, SR621100019WA, SR621100020WA, SR621100021WA, SR621100022WA, SR621100023WA, SR621100024WA, SR621100025WA; Model Number 6160000-003-779424, Serial Numbers: SR621110008WA; Model Number 6160000-003-779960, Serial Numbers: SR621110007WA; Model Number 6160000-003-781926, Serial Numbers: SR621110003WA, SR621110004WA, SR621110005WA, SR621110006WA, SR621110002WA, SR621110001WA; Model Number 6160000-003-783867, Serial Numbers: SR621120059WA, SR621150057WA, SR621150056WA, SR621260011WA, SR621420002WA, SR621420001WA, SR621430008WA, SR621472004WA, SR621472001WA, SR621472002WA, SR621472003WA, SR621472005WA, SR621472006WA, SR621472007WA, SR621472008WA, SR621472009WA, SR621472010WA, SR622332004WA, SR622332001WA, SR622332002WA, SR622332003WA, SR622332005WA, SR622332006WA, SR622332007WA, SR622332008WA, SR622332009WA, SR622332010WA, SR622332011WA, SR622332012WA; Model Number 6160000-003-784409, Serial Numbers: SR621120001WA, SR621120002WA, SR621120003WA, SR621120004WA, SR621120005WA, SR621120006WA, SR621120007WA, SR621120008WA, SR621120009WA, SR621120010WA, SR621120011WA, SR621120061WA, SR621120062WA, SR621120063WA, SR621120064WA, SR621120065WA, SR621120066WA, SR621120067WA, SR621120068WA, SR621120069WA, SR621120070WA, SR621120071WA, SR621120072WA, SR621120073WA; Model Number 6160000-003-786099, Serial Numbers: SR621120060WA; Model Number 6160000-003-787699, Serial Numbers: SR621210061WA, SR621150071WA, SR621150068WA, SR621150069WA, SR621150070WA, SR621150072WA, SR621150073WA, SR621150074WA, SR621230023WA, SR621410005WA, SR621410002WA, SR621410003WA, SR621410004WA, SR621410006WA, SR621410007WA, SR621410010WA, SR621410011WA, SR621462090WA, SR621462087WA, SR621462088WA, SR621462089WA, SR621462091WA, SR621462092WA, SR621462093WA, SR621462094WA, SR621462095WA, SR622012028WA, SR622012023WA, SR622012024WA, SR622012025WA, SR622012026WA, SR622012027WA, SR622012030WA, SR622012031WA, SR622012032WA, SR622012033WA, SR622012034WA, SR622012035WA, SR622012036WA, SR622012038WA, SR622012039WA, SR622012040WA, SR622012041WA, SR622012043WA, SR622012045WA, SR622012048WA, SR622012049WA, SR622012050WA, SR622022051WA, SR622022052WA, SR622022053WA, SR622022054WA, SR622022055WA, SR622022056WA, SR622022057WA, SR622022058WA, SR622022059WA, SR622022060WA, SR622022061WA, SR622022062WA, SR622012047WA, SR622012029WA, SR622012037WA, SR622012042WA, SR622012044WA, SR622012046WA, SR622072023WA, SR622072020WA, SR622072021WA, SR622072022WA, SR622072024WA, SR622072025WA, SR622112042WA, SR622112043WA, SR622112048WA, SR622112049WA, SR622112050WA, SR622112054WA, SR622112051WA, SR622112052WA, SR622112053WA, SR622112055WA, SR622112056WA, SR622142001WA, SR622112044WA, SR622112045WA, SR622112046WA, SR622112047WA, SR621502012WA, SR621502007WA, SR621502008WA, SR621502009WA, SR621502010WA, SR621502011WA, SR621210063WA, SR621462096WA, SR622352276WA, SR622352273WA, SR622352274WA, SR622352275WA, SR622352277WA, SR622352278WA, SR622362315WA, SR622362314WA, SR622362279WA, SR622362280WA, SR622362281WA, SR622362282WA, SR622362283WA, SR622362284WA, SR622362285WA, SR622362286WA; Model Number 6160000-003-789100, Serial Numbers: SR621380109WA, SR621280022WA, SR621380055WA, SR621380058WA, SR621492034WA, SR621492076WA, SR621492077WA, SR621492078WA, SR621492068WA, SR621492069WA, SR621492070WA, SR621492071WA, SR621492072WA, SR621492074WA, SR621492075WA, SR621380108WA, SR621492049WA, SR621492048WA, SR621492050WA, SR621492060WA, SR621492059WA, SR621492061WA, SR621492062WA, SR621492054WA, SR621492055WA, SR621492056WA, SR621492057WA, SR621170034WA, SR621170035WA, SR621170036WA, SR621170037WA, SR621170038WA, SR621170039WA, SR621170040WA, SR621170043WA, SR621170041WA, SR621170042WA, SR621170044WA, SR621250042WA, SR621270010WA, SR621190036WA, SR621380120WA, SR621380034WA, SR621380097WA, SR621380119WA, SR621380096WA, SR621270006WA, SR621170047WA, SR621170048WA, SR621170085WA, SR621170086WA, SR621170087WA, SR621250009WA, SR621250004WA, SR621250005WA, SR621250006WA, SR621250007WA, SR621250008WA, SR621250010WA, SR621250011WA, SR621250012WA, SR621250013WA, SR621250014WA, SR621250015WA, SR621250016WA, SR621250024WA, SR621250021WA, SR621250023WA, SR621250025WA, SR621250026WA, SR621250027WA, SR621250028WA, SR621250029WA, SR621250030WA, SR621250031WA, SR621250035WA, SR621250032WA, SR621250033WA, SR621250034WA, SR621250020WA, SR621250019WA, SR621270011WA, SR621370036WA, SR621370037WA, SR621380121WA, SR621380060WA, SR621492101WA, SR621492058WA, SR621492073WA, SR621280025WA, SR621280026WA, SR621380038WA, SR621360129WA, SR621360130WA, SR621360131WA, SR621280010WA, SR621280011WA, SR621280012WA, SR621280013WA, SR621280014WA, SR621280015WA, SR621280016WA, SR621280017WA, SR621492035WA, SR621370035WA, SR621250059WA, SR621250058WA, SR621250060WA, SR621250064WA, SR621250061WA, SR621250062WA, SR621250063WA, SR621250065WA, SR621250066WA, SR621250067WA, SR621250068WA, SR621270005WA, SR621190039WA, SR621190040WA, SR621230017WA, SR621270013WA, SR621270012WA, SR621270014WA, SR621370031WA, SR621370028WA, SR621370029WA, SR621370030WA, SR621370032WA, SR621370033WA, SR621370034WA, SR621420013WA, SR621492102WA, SR621140004WA, SR621140001WA, SR621140002WA, SR621140003WA, SR621140005WA, SR621140006WA, SR621140007WA, SR621140008WA, SR621140009WA, SR621140010WA, SR621140012WA, SR621140013WA, SR621140014WA, SR621140015WA, SR621140016WA, SR621140017WA, SR621140018WA, SR621140019WA, SR621140020WA, SR621140021WA, SR621140045WA, SR621140046WA, SR621140047WA, SR621150020WA, SR621150017WA, SR621150016WA, SR621150018WA, SR621150019WA, SR621270026WA, SR621270027WA, SR621270028WA, SR621270029WA, SR621270030WA, SR621380033WA, SR621420026WA, SR621492018WA, SR621380061WA, SR621380062WA, SR621380063WA, SR621380064WA, SR621492103WA, SR621170049WA, SR621190026WA, SR621190027WA, SR621190028WA, SR621190029WA, SR621190030WA, SR621190031WA, SR621190032WA, SR621190033WA, SR621190034WA, SR621190035WA, SR621220029WA, SR621220030WA, SR621220026WA, SR621220027WA, SR621220028WA, SR621240004WA, SR621240001WA, SR621240002WA, SR621240003WA, SR621240005WA, SR621360128WA, SR621210038WA, SR621210039WA, SR621210040WA, SR621210041WA, SR621210042WA, SR621210043WA, SR621210044WA, SR621210048WA, SR621210045WA, SR621210046WA, SR621210047WA, SR621210049WA, SR621210050WA, SR621210051WA, SR621210052WA, SR621210053WA, SR621220010WA, SR621220006WA, SR621220007WA, SR621220008WA, SR621220009WA, SR621220011WA, SR621220012WA, SR621220013WA, SR621220014WA, SR621220015WA, SR621220016WA, SR621220017WA, SR621220018WA, SR621220019WA, SR621150038WA, SR621150036WA, SR621150039WA, SR621150040WA, SR621150042WA, SR621150029WA, SR621150026WA, SR621150028WA, SR621150033WA, SR621150034WA, SR621170017WA, SR621170018WA, SR621170019WA, SR621170020WA, SR621170021WA, SR621170022WA, SR621170023WA, SR621170024WA, SR621170025WA, SR621170026WA, SR621170027WA, SR621170028WA, SR621170033WA, SR621170082WA, SR621170083WA, SR621170084WA, SR621190041WA, SR621200001WA, SR621210031WA, SR621210032WA, SR621210033WA, SR621210034WA, SR621220020WA, SR621220021WA, SR621220022WA, SR621220023WA, SR621220024WA, SR621230021WA, SR621250036WA, SR621250037WA, SR621250038WA, SR621250039WA, SR621250040WA, SR621250041WA, SR621250049WA, SR621250050WA, SR621250051WA, SR621250052WA, SR621250053WA, SR621250054WA, SR621270018WA, SR621380041WA, SR621380042WA, SR621380043WA, SR621380056WA, SR621380057WA, SR621380059WA, SR621380030WA, SR621380029WA, SR621380031WA, SR621380036WA, SR621380040WA, SR621420021WA, SR621420022WA, SR621420023WA, SR621420024WA, SR621492017WA, SR621492019WA, SR621492020WA, SR621492021WA, SR621492029WA, SR621492030WA, SR621492031WA, SR621492032WA, SR621492033WA, SR621492085WA, SR621492086WA, SR621492087WA, SR621492063WA, SR621492064WA, SR621492065WA, SR621492066WA, SR621492067WA, SR621150030WA, SR621150023WA, SR621150021WA, SR621150022WA, SR621150024WA, SR621150025WA, SR621210025WA, SR621210022WA, SR621210023WA, SR621210024WA, SR621210026WA, SR621210027WA, SR621210028WA, SR621210029WA, SR621210020WA, SR621210021WA, SR621190038WA, SR621150037WA, SR621210030WA, SR621240006WA, SR621250048WA, SR621270044WA, SR621270045WA, SR621270046WA, SR621270047WA, SR621270048WA, SR621270049WA, SR621270050WA, SR621270051WA, SR621270052WA, SR621270053WA, SR621270054WA, SR621280001WA, SR621492088WA, SR621492089WA, SR621492090WA, SR621492091WA, SR621492092WA, SR621492093WA, SR621492094WA, SR621492095WA, SR621230020WA, SR621230019WA, SR621150035WA, SR621150041WA, SR621150027WA, SR621160005WA, SR621170030WA, SR621170029WA, SR621170031WA, SR621170032WA, SR621492039WA, SR621492036WA, SR621492037WA, SR621492038WA, SR621492040WA, SR621492041WA, SR621492042WA, SR621492043WA, SR621492044WA, SR621492045WA, SR621492046WA, SR621492047WA, SR621250057WA, SR621270022WA, SR621270023WA, SR621270019WA, SR621270020WA, SR621270021WA, SR621190019WA, SR621270025WA, SR621270024WA, SR621380037WA, SR621250055WA, SR621492096WA, SR621160008WA, SR621220025WA, SR621270015WA, SR621270016WA, SR621270017WA, SR621280021WA, SR621360124WA, SR621360123WA, SR621420016WA, SR621420017WA, SR621420018WA, SR621420019WA, SR621420020WA, SR621380039WA, SR621492023WA, SR621280023WA, SR621280024WA, SR621360099WA, SR621360096WA, SR621360097WA, SR621360098WA, SR621360100WA, SR621360101WA, SR621360102WA, SR621360103WA, SR621370038WA, SR621370039WA, SR621420027WA, SR621140024WA, SR621140025WA, SR621140040WA, SR621140037WA, SR621140038WA, SR621140039WA, SR621140041WA, SR621140042WA, SR621140043WA, SR621140044WA, SR621140048WA, SR621140026WA, SR621140027WA, SR621140028WA, SR621140029WA, SR621140030WA, SR621140031WA, SR621140032WA, SR621140033WA, SR621140034WA, SR621140036WA, SR621140035WA, SR621170096WA, SR621170097WA, SR621170098WA, SR621170099WA, SR621170100WA, SR621170101WA, SR621170102WA, SR621170103WA, SR621170104WA, SR621170105WA, SR621170106WA, SR621180064WA, SR621180059WA, SR621180060WA, SR621180061WA, SR621180062WA, SR621180063WA, SR621180065WA, SR621180066WA, SR621180067WA, SR621180068WA, SR621190014WA, SR621190011WA, SR621190012WA, SR621190013WA, SR621280034WA, SR621280031WA, SR621280032WA, SR621280033WA, SR621280035WA, SR621280036WA, SR621280037WA, SR621280038WA, SR621280039WA, SR621280040WA, SR621280041WA, SR621280042WA, SR621280043WA, SR621280044WA, SR621280045WA, SR621280046WA, SR621280047WA, SR621280048WA, SR621280049WA, SR621280050WA, SR621280027WA, SR621280028WA, SR621280029WA, SR621280030WA, SR621370040WA, SR621370041WA, SR621370042WA, SR621370043WA, SR621370048WA, SR621370044WA, SR621370045WA, SR621370046WA, SR621370047WA, SR621370049WA, SR621370050WA, SR621370051WA, SR621370052WA, SR621370053WA, SR621370054WA, SR621370055WA, SR621370056WA, SR621370057WA, SR621370058WA, SR621370059WA, SR621370060WA, SR621370061WA, SR621370062WA, SR621370063WA, SR621370071WA, SR621370068WA, SR621370069WA, SR621370070WA, SR621370072WA, SR621370073WA, SR621370074WA, SR621370075WA, SR621370076WA, SR621370067WA, SR621370064WA, SR621370065WA, SR621370066WA, SR621380077WA, SR621420038WA, SR621420033WA, SR621420034WA, SR621420035WA, SR621420036WA, SR621420037WA, SR621420039WA, SR621420040WA, SR621420041WA, SR621420042WA, SR621420043WA, SR621420044WA, SR621420045WA, SR621420046WA, SR621420047WA, SR621420048WA, SR621420049WA, SR621420050WA, SR621420051WA, SR621420052WA, SR621420053WA, SR621420054WA, SR621492004WA, SR621492001WA, SR621492002WA, SR621492003WA, SR621492005WA, SR621492006WA, SR621492007WA, SR621492008WA, SR621492009WA, SR621492010WA, SR621492011WA, SR621492012WA, SR621492013WA, SR621492014WA, SR621492015WA, SR621492016WA, SR621370027WA, SR621380032WA, SR621380035WA, SR621250022WA, SR621250043WA, SR621250044WA, SR621250045WA, SR621250046WA, SR621250047WA, SR621270007WA, SR621270008WA, SR621280018WA, SR621280019WA, SR621280020WA, SR621380080WA, SR621380081WA, SR621380082WA, SR621380083WA, SR621380044WA, SR621380045WA, SR621420015WA, SR621420005WA, SR621420006WA, SR621492097WA, SR621492098WA, SR621492099WA, SR621492100WA, SR621380103WA, SR621380104WA, SR621380105WA, SR621380106WA, SR621380107WA, SR621380046WA, SR621380047WA, SR621380048WA, SR621420028WA, SR621170011WA, SR621170012WA, SR621170013WA, SR621170014WA, SR621170015WA, SR621170007WA, SR621170004WA, SR621170005WA, SR621170006WA, SR621170008WA, SR621150015WA, SR621420025WA, SR621380093WA, SR621380094WA, SR621380095WA, SR621200002WA, SR621200003WA, SR621200004WA, SR621200005WA, SR621210007WA, SR621210004WA, SR621210005WA, SR621210006WA, SR621210008WA, SR621210009WA, SR621270036WA, SR621270034WA, SR621270035WA, SR621270037WA, SR621270038WA, SR621270039WA, SR621270040WA, SR621270041WA, SR621270042WA, SR621270043WA, SR621150007WA, SR621150008WA, SR621140049WA, SR621140050WA, SR621150001WA, SR621150002WA, SR621150003WA, SR621150004WA, SR621150005WA, SR621150006WA, SR621170050WA, SR621170051WA, SR621170080WA, SR621170077WA, SR621170078WA, SR621170079WA, SR621170081WA, SR621280006WA, SR621280007WA, SR621280008WA, SR621280009WA, SR621420029WA, SR621420030WA, SR621420031WA, SR621420032WA, SR621150013WA, SR621150014WA, SR621360106WA, SR621360107WA, SR621380124WA, SR621380122WA, SR621380123WA, SR621380125WA, SR621380126WA, SR621360132WA, SR621270031WA, SR621270032WA, SR621210036WA, SR621210037WA, SR621380084WA, SR621380085WA, SR621380086WA, SR621380087WA, SR621380088WA, SR621380089WA, SR621380090WA, SR621380091WA, SR621140022WA, SR621140023WA, SR621170045WA, SR621170046WA, SR621270009WA, SR621370136WA, SR621370137WA, SR621370138WA, SR621370139WA, SR621370140WA, SR621370141WA, SR621370142WA, SR621370143WA, SR621370144WA, SR621370145WA, SR621380100WA, SR621380098WA, SR621380099WA, SR621380101WA, SR621380102WA, SR621380026WA, SR621380027WA, SR621380028WA, SR621380021WA, SR621380022WA, SR621380023WA, SR621380024WA, SR621380025WA, SR621380015WA, SR621380016WA, SR621380017WA, SR621380018WA, SR621380019WA, SR621380020WA, SR621230018WA, SR621190037WA, SR621492022WA, SR621190020WA, SR621190025WA, SR621190022WA, SR621190023WA, SR621190024WA, SR621250056WA, SR621280005WA, SR621360118WA, SR621360115WA, SR621360116WA, SR621360117WA, SR621360119WA, SR621360120WA, SR621360108WA, SR621360109WA, SR621360110WA, SR621360111WA, SR621360112WA, SR621360113WA, SR621360114WA, SR621360121WA, SR621360122WA, SR621380049WA, SR621380050WA, SR621380051WA, SR621380052WA, SR621380053WA, SR621380054WA, SR621492082WA, SR621492079WA, SR621492080WA, SR621492081WA, SR621380092WA, SR621270033WA, SR621360127WA, SR621492024WA, SR621492025WA, SR621492026WA, SR621492027WA, SR621492028WA, SR621170094WA, SR621170093WA, SR621170095WA, SR621360125WA, SR621360126WA, SR621210035WA, SR621380110WA, SR621380111WA, SR621380115WA, SR621380112WA, SR621380113WA, SR621380114WA, SR621380116WA, SR621380117WA, SR621380118WA, SR621420014WA, SR621360104WA, SR621360105WA, SR621190015WA, SR621190016WA, SR621190017WA, SR621190018WA, SR621140011WA, SR621280003WA, SR621280004WA, SR621280002WA, SR621150043WA, SR621420010WA, SR621420011WA, SR621420012WA, SR621420008WA, SR621420007WA, SR621420009WA, SR621360133WA, SR621370134WA, SR621370135WA, SR621150044WA, SR621150045WA, SR621150046WA, SR621150047WA, SR621150048WA, SR621150049WA, SR621150031WA, SR621150032WA, SR621150050WA, SR621160006WA, SR621160007WA, SR621170088WA, SR621170089WA, SR621170090WA, SR621170091WA, SR621170092WA, SR621210010WA, SR621210011WA, SR621210012WA, SR621210013WA, SR621210014WA, SR621210015WA, SR621210016WA, SR621210017WA, SR621210018WA, SR621210019WA, SR621380078WA, SR621380079WA, SR621150009WA, SR621150010WA, SR621150011WA, SR621150012WA, SR621492083WA, SR621492084WA; Model Number 6160000-003-790654, Serial Numbers: SR621130001WA, SR621130002WA, SR621130003WA, SR621130004WA, SR621130005WA, SR621130006WA, SR621130007WA, SR621130008WA, SR621130009WA, SR621130010WA; Model Number 6160000-003-791238, Serial Numbers: SR621360044WA, SR621360045WA, SR621270139WA, SR621300407WA, SR621360027WA, SR621360024WA, SR621360025WA, SR621360026WA, SR621360028WA, SR621360029WA, SR621360030WA, SR621360031WA, SR621360032WA, SR621360033WA, SR621360034WA, SR621360035WA, SR621360036WA, SR621360037WA, SR621360038WA, SR621360039WA, SR621360040WA, SR621360041WA, SR621360042WA, SR621360043WA, SR621360046WA, SR621360047WA, SR621360006WA, SR621360007WA, SR621360008WA, SR621360009WA, SR621360010WA, SR621360011WA, SR621360012WA, SR621360016WA, SR621360013WA, SR621360014WA, SR621360015WA, SR621360017WA, SR621360018WA, SR621360019WA, SR621360020WA, SR621360021WA, SR621360022WA, SR621360023WA, SR621360086WA, SR621360087WA, SR621360088WA, SR621360089WA, SR621360090WA, SR621360091WA, SR621360092WA, SR621360072WA, SR621360073WA, SR621360074WA, SR621360075WA, SR621360076WA, SR621360077WA, SR621360078WA, SR621360079WA, SR621360080WA, SR621360081WA, SR621360082WA, SR621360083WA, SR621360084WA, SR621360085WA, SR621360093WA, SR621360094WA, SR621360095WA, SR621360048WA, SR621360049WA, SR621360050WA, SR621360051WA, SR621360052WA, SR621360053WA, SR621360054WA, SR621360055WA, SR621360056WA, SR621360057WA, SR621360061WA, SR621360058WA, SR621360059WA, SR621360060WA, SR621360062WA, SR621360063WA, SR621360064WA, SR621360065WA, SR621360066WA, SR621360067WA, SR621360068WA, SR621360069WA, SR621360070WA, SR621360071WA, SR621410009WA, SR621410008WA, SR621150077WA, SR621220038WA, SR621220037WA, SR621390006WA, SR621390005WA, SR622352037WA, SR621300412WA, SR621462011WA, SR621462012WA, SR621462013WA, SR621462014WA, SR621462010WA, SR622082002WA, SR622082001WA, SR622352032WA, SR622352033WA, SR622352034WA, SR622352035WA, SR621190021WA, SR621300406WA, SR621300413WA, SR621300411WA, SR621400004WA, SR621400001WA, SR621400002WA, SR621400003WA, SR621400005WA, SR621410015WA, SR621410012WA, SR621410013WA, SR621410014WA, SR621410016WA, SR621410017WA, SR621410018WA, SR621410019WA, SR621410020WA, SR621410021WA, SR621410022WA, SR621410026WA, SR621410023WA, SR621410024WA, SR621410025WA, SR621410027WA, SR621410028WA, SR621410029WA, SR621440021WA, SR621452075WA, SR621452076WA, SR622072015WA, SR622072017WA, SR622072018WA, SR622072019WA, SR622072013WA, SR622072014WA, SR622072016WA, SR622142003WA, SR622142002WA, SR621260017WA, SR622072004WA, SR622072003WA, SR622072005WA, SR621300404WA, SR621150075WA, SR621150076WA, SR621150063WA, SR621150066WA, SR621150067WA, SR621150060WA, SR621150061WA, SR621150062WA, SR621150064WA, SR621150065WA, SR621220034WA, SR621220032WA, SR621220033WA, SR621220003WA, SR621220035WA, SR621220036WA, SR621220039WA, SR621250002WA, SR621300400WA, SR621300405WA, SR621300409WA, SR621300408WA, SR621300410WA, SR621400007WA, SR621400006WA, SR621452081WA, SR621452080WA, SR621440020WA, SR621452074WA, SR621452077WA, SR621452078WA, SR621452079WA, SR621462048WA, SR621462045WA, SR621462046WA, SR621462047WA, SR621462049WA, SR621462050WA, SR621462051WA, SR622072006WA, SR622072007WA, SR622072008WA, SR622072009WA, SR622072010WA, SR622072011WA, SR622072012WA, SR622072027WA, SR622072026WA, SR622352036WA, SR622352041WA, SR622352038WA, SR622352039WA, SR622352040WA, SR622352042WA, SR622352058WA, SR622352057WA, SR622352054WA, SR622352053WA, SR622352048WA, SR622352045WA, SR622352046WA, SR622352047WA, SR622352049WA, SR622362037WA, SR622362038WA, SR622362039WA, SR622362040WA, SR622362041WA, SR622362042WA, SR622362043WA, SR622362044WA, SR622362048WA, SR622362045WA, SR622362046WA, SR622362047WA, SR622362079WA, SR621220001WA; Model Number 6160000-003-791758, Serial Numbers: SR621280053WA, SR621280051WA, SR621280052WA; Model Number 6160000-003-792034, Serial Numbers: SR622192003WA, SR622192004WA, SR622152021WA, SR621130011WA, SR621130012WA, SR621130013WA, SR621130014WA, SR621130015WA; Model Number 6160000-003-794507, Serial Numbers: SR621210001WA, SR621210002WA, SR621210003WA; Model Number 6160000-003-794812, Serial Numbers: SR621210054WA; Model Number 6160000-003-795091, Serial Numbers: SR621380127WA, SR621380128WA, SR621380008WA, SR621380005WA, SR621380007WA, SR621380009WA, SR621380010WA, SR621380011WA, SR621380012WA, SR621380013WA, SR621380014WA, SR621512071WA, SR621512068WA, SR621512069WA, SR621512070WA, SR621512075WA, SR621512072WA, SR621512073WA, SR621512074WA, SR621512076WA, SR621512077WA, SR621512078WA, SR621512079WA, SR621512080WA, SR621512081WA, SR621512082WA, SR621512083WA, SR621512084WA, SR621512085WA, SR621512086WA, SR621512087WA, SR621512088WA, SR621512089WA, SR621512090WA, SR621512091WA, SR621512092WA, SR621512093WA, SR621512094WA, SR621512095WA, SR621512096WA, SR621512097WA, SR621512098WA, SR621512099WA, SR621512100WA, SR621512101WA, SR621512102WA, SR621512103WA, SR621502034WA, SR621502035WA, SR621502036WA, SR621502037WA, SR621502038WA, SR621502039WA, SR621502043WA, SR621502040WA, SR621502041WA, SR621502042WA, SR621502044WA, SR621502045WA, SR621502046WA, SR621502047WA, SR621502048WA, SR621502049WA, SR621502050WA, SR621502051WA, SR621502052WA, SR621502053WA, SR621502054WA, SR621512001WA, SR621512002WA, SR621512003WA, SR621512004WA, SR621512005WA, SR621512006WA, SR621512007WA, SR621512008WA, SR621512009WA, SR621512010WA, SR621512011WA, SR621502023WA, SR621502020WA, SR621502021WA, SR621502022WA, SR62
Quantity Affected: 3905 units
Reason for Recall
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-16
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0731-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29