RecallHawk
Class II Recall

B125M Patient Monitor, REF 6160000-005-XXXXXXX

GE Medical Systems, LLC

Summary

The FDA issued a Class II for B125M Patient Monitor, REF 6160000-005-XXXXXXX 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-0733-2023

Action Date

2022-12-28

Status

Ongoing

Category

device

Product Description

B125M Patient Monitor, REF 6160000-005-XXXXXXX

Lot/Code Info: UDI/DI 00840682146791: Model Number 6160000-005, Serial Numbers: SR821512013WA, SR821512014WA, SR821512017WA, SR821512016WA, SR821512015WA, SR821430047WA, SR821430049WA, SR821430048WA, SR821430050WA, SR821410068WA, SR821170021WA, SR822062011WA, SR821260059WA, SR822072018WA, SR822072016WA, SR822072015WA, SR822072022WA, SR822072021WA, SR822072020WA, SR822072019WA, SR822072017WA, SR822072014WA, SR822072013WA, SR821170023WA, SR821180036WA, SR821180037WA, SR821180035WA, SR821180038WA, SR821180039WA, SR821210003WA, SR821210001WA, SR821210002WA, SR821210004WA, SR821210005WA, SR821210006WA, SR821210007WA, SR821210008WA, SR821210009WA, SR821210010WA, SR821250021WA, SR821250027WA, SR821250022WA, SR821250023WA, SR821250024WA, SR821250025WA, SR821260010WA, SR822072012WA, SR822072011WA, SR822072003WA, SR822072005WA, SR822072010WA, SR822072006WA, SR822072009WA, SR822072008WA, SR822072007WA, SR822072004WA, SR821260012WA, SR822062004WA, SR822062005WA, SR822062006WA, SR822290015SA, SR822300010SA, SR822300002SA, SR822300005SA, SR822300007SA, SR822300008SA, SR822300004SA, SR822290019SA, SR822300006SA, SR822290012SA, SR822300001SA, SR822300009SA, SR822290017SA, SR822290018SA, SR822300003SA, SR821170005WA, SR821170020WA, SR821170017WA, SR821170018WA, SR821170019WA, SR821170006WA, SR821410025WA, SR821410001WA, SR821410023WA, SR821410024WA, SR822062010WA, SR821170030WA, SR821170029WA, SR821260056WA, SR821260066WA, SR821260065WA, SR821260064WA, SR821260060WA, SR821260058WA, SR821170033WA, SR821170034WA, SR821260061WA, SR821260063WA, SR821260057WA, SR821260067WA, SR821260001WA, SR821260047WA, SR821260005WA, SR821260069WA, SR821260002WA, SR821260046WA, SR821260049WA, SR821260003WA, SR821260051WA, SR821260068WA, SR821260004WA, SR821260006WA, SR821260052WA, SR821260050WA, SR821410022WA, SR821410021WA, SR821410020WA, SR821410018WA, SR821410017WA, SR821410019WA, SR821350118WA, SR821260018WA, SR821260016WA, SR821260015WA, SR821350119WA, SR821350209WA, SR821350214WA, SR821350117WA, SR821390095WA, SR821260022WA, SR821260020WA, SR821350210WA, SR821350212WA, SR821260019WA, SR821350220WA, SR821350211WA, SR821390093WA, SR821260017WA, SR821350219WA, SR821350115WA, SR821350114WA, SR821390091WA, SR821390089WA, SR821260021WA, SR821260014WA, SR821260026WA, SR821260025WA, SR821260024WA, SR821260023WA, SR821260009WA, SR821260008WA, SR821260011WA, SR821260007WA, SR821350216WA, SR821350218WA, SR821350217WA, SR821350215WA, SR821350213WA, SR821390094WA, SR821350116WA, SR821260013WA, SR821390092WA, SR821390090WA, SR822062014WA, SR822062013WA, SR822062009WA, SR822062012WA, SR822062008WA, SR822062001WA, SR822062007WA, SR822062003WA, SR821410050WA, SR821170026WA, SR821170024WA, SR821170027WA, SR821170022WA, SR821250037WA, SR821250028WA, SR821250030WA, SR821250031WA, SR821250035WA, SR821250038WA, SR821250029WA, SR821250033WA, SR821250034WA, SR821250036WA, SR821250032WA, SR821250039WA, SR821250040WA, SR821260041WA, SR821260071WA, SR821260077WA, SR821260040WA, SR821260070WA, SR821260072WA, SR821260073WA, SR821260074WA, SR821260075WA, SR821260076WA, SR821260028WA, SR821260038WA, SR821260039WA, SR821260029WA, SR821260037WA, SR821260031WA, SR821410083WA, SR821410080WA, SR821410078WA, SR821410075WA, SR821410073WA, SR821410082WA, SR821410079WA, SR821410077WA, SR821410081WA, SR821410070WA, SR821410076WA, SR821410074WA, SR821410072WA, SR821410049WA, SR821410053WA, SR821410055WA, SR821410057WA, SR821410062WA, SR821410052WA, SR821410056WA, SR821410058WA, SR821410061WA, SR821410066WA, SR821410054WA, SR821410059WA, SR821410060WA, SR821410065WA, SR821410069WA, SR821410064WA, SR821260062WA, SR821410011WA, SR821410013WA, SR821410012WA, SR821410014WA, SR821410015WA, SR821410016WA, SR821410010WA, SR821390103WA, SR821390101WA, SR821410117WA, SR821410116WA, SR821410115WA, SR821410114WA, SR821410113WA, SR821410109WA, SR821410112WA, SR821410111WA, SR821410108WA, SR821410110WA, SR821410092WA, SR821410107WA, SR821410106WA, SR821410105WA, SR821410097WA, SR821410104WA, SR821410103WA, SR821410102WA, SR821410094WA, SR821410099WA, SR821410096WA, SR821410098WA, SR821410095WA, SR821410091WA, SR821410093WA, SR821410090WA, SR821410043WA, SR821410089WA, SR821410088WA, SR821410087WA, SR821410085WA, SR821410084WA, SR821410041WA, SR821410063WA, SR821410051WA, SR821410048WA, SR821410046WA, SR821410045WA, SR821410047WA, SR821410044WA, SR821410042WA, SR821410040WA, SR821410039WA, SR821410034WA, SR821410031WA, SR821410007WA, SR821410006WA, SR821410038WA, SR821410037WA, SR821410035WA, SR821410036WA, SR821410032WA, SR821410030WA, SR821410033WA, SR821410029WA, SR821410028WA, SR821410008WA, SR821410027WA, SR821410026WA, SR821410009WA, SR821410003WA, SR821390130WA, SR821390140WA, SR821390138WA, SR821390131WA, SR821390132WA, SR821390129WA, SR821410004WA, SR821390133WA, SR821410005WA, SR821390136WA, SR821390116WA, SR821410002WA, SR821390128WA, SR821390137WA, SR821390135WA, SR821390134WA, SR821390139WA, SR821390127WA, SR821390126WA, SR821390125WA, SR821390108WA, SR821390124WA, SR821390113WA, SR821390121WA, SR821390118WA, SR821390107WA, SR821390109WA, SR821390111WA, SR821390112WA, SR821390117WA, SR821390110WA, SR821390122WA, SR821390120WA, SR821390119WA, SR821390123WA, SR821390115WA, SR821390114WA, SR821390104WA, SR821390105WA, SR821390102WA, SR821390106WA, SR821260055WA, SR821260054WA, SR821170031WA, SR821170032WA, SR822062002WA, SR821410118WA, SR821410100WA, SR821410101WA, SR821410119WA, SR821260053WA, SR821260048WA, SR821210016WA, SR821210018WA, SR821210014WA, SR821210020WA, SR821230027WA, SR821230062WA, SR821230061WA, SR821230042WA, SR821230041WA, SR821230039WA, SR821230036WA, SR821230035WA, SR821230055WA, SR821230053WA, SR821230054WA, SR821230016WA, SR821230018WA, SR821230022WA, SR821230024WA, SR821230065WA, SR821472050WA, SR821472049WA, SR821472052WA, SR821472053WA, SR821472054WA, SR821472055WA, SR821472056WA, SR821472057WA, SR821472058WA, SR821472059WA, SR821472060WA, SR821472061WA, SR821472042WA, SR821472043WA, SR821472044WA, SR821472045WA, SR821472046WA, SR821472047WA, SR821472048WA, SR821472051WA, SR822082030WA, SR822082035WA, SR822082031WA, SR822082029WA, SR822082033WA, SR822082038WA, SR822082032WA, SR822082037WA, SR822082034WA, SR822082036WA, SR821230050WA, SR821230051WA, SR821210013WA, SR821230034WA, SR821230043WA, SR821230031WA, SR821230032WA, SR821230047WA, SR821230014WA, SR821230021WA, SR821230025WA, SR821230060WA, SR821230059WA, SR821230058WA, SR821230052WA, SR821380084WA, SR821210011WA, SR821210015WA, SR821230001WA, SR821230003WA, SR821230004WA, SR821230005WA, SR821230006WA, SR821230007WA, SR821230008WA, SR821230009WA, SR821230012WA, SR821230066WA, SR821230067WA, SR821230068WA, SR821230069WA, SR821230070WA, SR821230071WA, SR821230072WA, SR821230073WA, SR821230074WA, SR821230075WA, SR821230076WA, SR821230077WA, SR821230078WA, SR821230079WA, SR821230080WA, SR821230081WA, SR821230082WA, SR821230083WA, SR821230084WA, SR821230085WA, SR821230086WA, SR821230002WA, SR821230064WA, SR821230048WA, SR821230046WA, SR821230026WA, SR821230028WA, SR821210019WA, SR821230019WA, SR821230029WA, SR821230049WA, SR821210017WA, SR821230040WA, SR821230038WA, SR821230037WA, SR821230017WA, SR821230013WA, SR821230015WA, SR821230020WA, SR821230023WA, SR821230030WA, SR821230063WA, SR821230056WA, SR821230057WA, SR821210012WA, SR821270043WA, SR821270046WA, SR821270047WA, SR821270045WA, SR821270044WA, SR821430033WA, SR822092010WA, SR822092009WA, SR821430031WA, SR822092008WA, SR821270048WA, SR821430032WA, SR821270081WA, SR821270082WA, SR821330039WA, SR821330040WA, SR821330041WA, SR821330042WA, SR821330043WA, SR821330044WA, SR821330045WA, SR821330046WA, SR821330047WA, SR821330048WA, SR821330049WA, SR821330050WA, SR821330051WA, SR821330052WA, SR821330053WA, SR821330054WA, SR821330055WA, SR821330056WA, SR821330057WA, SR821330058WA, SR821330059WA, SR821330060WA, SR821330061WA, SR821330062WA, SR821330063WA, SR821330064WA, SR821330065WA, SR821350001WA, SR821350002WA, SR821350003WA, SR821350004WA, SR821350005WA, SR821350006WA, SR821350007WA, SR821350008WA, SR821350009WA, SR821350010WA, SR821350011WA, SR821350012WA, SR821350013WA, SR821350014WA, SR821350015WA, SR821350016WA, SR821350017WA, SR821350018WA, SR821350019WA, SR821350020WA, SR821350021WA, SR821350022WA, SR821350023WA, SR821350024WA, SR821350025WA, SR821350026WA, SR821350027WA, SR821350028WA, SR821350029WA, SR821350030WA, SR821350031WA, SR821350032WA, SR821350033WA, SR821350034WA, SR821350035WA, SR821350036WA, SR821350037WA, SR821350038WA, SR821350039WA, SR821350040WA, SR821350041WA, SR821350126WA, SR821350127WA, SR821350128WA, SR821350129WA, SR821350130WA, SR821350131WA, SR821350132WA, SR821350133WA, SR821350134WA, SR821350135WA, SR821350136WA, SR821350137WA, SR821350138WA, SR821350139WA, SR821350140WA, SR821350141WA, SR821350145WA, SR821350142WA, SR821350143WA, SR821350144WA, SR821350146WA, SR821350147WA, SR821350148WA, SR821340018WA, SR821340015WA, SR821340016WA, SR821340017WA, SR821340019WA, SR821340020WA, SR821340021WA, SR821340022WA, SR821340023WA, SR821340024WA, SR821340025WA, SR821340026WA, SR821340027WA, SR821340028WA, SR821340029WA, SR821340110WA, SR821340111WA, SR821340112WA, SR821340113WA, SR821340114WA, SR821340115WA, SR821340116WA, SR821340117WA, SR821340118WA, SR821340119WA, SR821340120WA, SR821340121WA, SR821340122WA, SR821340123WA, SR821340124WA, SR821340125WA, SR821340094WA, SR821340095WA, SR821340096WA, SR821340097WA, SR821340098WA, SR821340099WA, SR821340100WA, SR821340101WA, SR821340102WA, SR821340103WA, SR821340104WA, SR821340105WA, SR821340106WA, SR821340107WA, SR821340108WA, SR821340109WA, SR821340078WA, SR821340079WA, SR821340080WA, SR821340081WA, SR821340082WA, SR821340083WA, SR821340084WA, SR821340085WA, SR821340086WA, SR821340087WA, SR821340088WA, SR821340089WA, SR821340093WA, SR821340090WA, SR821340091WA, SR821340092WA, SR821340062WA, SR821340063WA, SR821340064WA, SR821340065WA, SR821340066WA, SR821340067WA, SR821340068WA, SR821340069WA, SR821340070WA, SR821340071WA, SR821340072WA, SR821340073WA, SR821340074WA, SR821340075WA, SR821340076WA, SR821340077WA, SR821340046WA, SR821340047WA, SR821340048WA, SR821340049WA, SR821340050WA, SR821340051WA, SR821340052WA, SR821340053WA, SR821340054WA, SR821340055WA, SR821340056WA, SR821340057WA, SR821340058WA, SR821340059WA, SR821340060WA, SR821340061WA, SR821340030WA, SR821340031WA, SR821340032WA, SR821340033WA, SR821340034WA, SR821340035WA, SR821340036WA, SR821340037WA, SR821340038WA, SR821340039WA, SR821340040WA, SR821340041WA, SR821340042WA, SR821340043WA, SR821340044WA, SR821340045WA, SR821340001WA, SR821340002WA, SR821340003WA, SR821340004WA, SR821340005WA, SR821340006WA, SR821340007WA, SR821340008WA, SR821340009WA, SR821340010WA, SR821340011WA, SR821340012WA, SR821340013WA, SR821340014WA, SR821360313WA, SR821360314WA, SR821360315WA, SR821360316WA, SR821360317WA, SR821360318WA, SR821360319WA, SR821360320WA, SR821360324WA, SR821360325WA, SR821360326WA, SR821360327WA, SR821360328WA, SR821360329WA, SR821360330WA, SR821360331WA, SR821360332WA, SR821360333WA, SR821360334WA, SR821360335WA, SR821360293WA, SR821360294WA, SR821360295WA, SR821360296WA, SR821360297WA, SR821360298WA, SR821360299WA, SR821360300WA, SR821360301WA, SR821360302WA, SR821360303WA, SR821360304WA, SR821360305WA, SR821360306WA, SR821360307WA, SR821360308WA, SR821360309WA, SR821360310WA, SR821360311WA, SR821360312WA, SR821350273WA, SR821350274WA, SR821360275WA, SR821360276WA, SR821360277WA, SR821360278WA, SR821360279WA, SR821360280WA, SR821360281WA, SR821360282WA, SR821360283WA, SR821360284WA, SR821360285WA, SR821360286WA, SR821360287WA, SR821360288WA, SR821360289WA, SR821360290WA, SR821360291WA, SR821360292WA, SR821350253WA, SR821350254WA, SR821350255WA, SR821350256WA, SR821350257WA, SR821350258WA, SR821350259WA, SR821350260WA, SR821350261WA, SR821350262WA, SR821350263WA, SR821350264WA, SR821350265WA, SR821350266WA, SR821350267WA, SR821350268WA, SR821350269WA, SR821350270WA, SR821350271WA, SR821350272WA, SR821350233WA, SR821350234WA, SR821350235WA, SR821350236WA, SR821350237WA, SR821350238WA, SR821350239WA, SR821350240WA, SR821350241WA, SR821350242WA, SR821350243WA, SR821350244WA, SR821350245WA, SR821350246WA, SR821350247WA, SR821350248WA, SR821350249WA, SR821350250WA, SR821350251WA, SR821350252WA, SR821350223WA, SR821350224WA, SR821350225WA, SR821350226WA, SR821350227WA, SR821350228WA, SR821350229WA, SR821350230WA, SR821350231WA, SR821350232WA, SR821360051WA, SR821360052WA, SR821360053WA, SR821360054WA, SR821360055WA, SR821360056WA, SR821360057WA, SR821360058WA, SR821360059WA, SR821360060WA, SR821360061WA, SR821360062WA, SR821360063WA, SR821360064WA, SR821360065WA, SR821360066WA, SR821360067WA, SR821360068WA, SR821360069WA, SR821360070WA, SR821360031WA, SR821360032WA, SR821360033WA, SR821360034WA, SR821360035WA, SR821360036WA, SR821360037WA, SR821360038WA, SR821360039WA, SR821360040WA, SR821360041WA, SR821360042WA, SR821360043WA, SR821360044WA, SR821360045WA, SR821360046WA, SR821360047WA, SR821360048WA, SR821360049WA, SR821360050WA, SR821360021WA, SR821360022WA, SR821360023WA, SR821360024WA, SR821360025WA, SR821360026WA, SR821360027WA, SR821360028WA, SR821360029WA, SR821360030WA, SR821350221WA, SR821350222WA, SR821360001WA, SR821360002WA, SR821360003WA, SR821360004WA, SR821360005WA, SR821360006WA, SR821360007WA, SR821360008WA, SR821360009WA, SR821360010WA, SR821360011WA, SR821360012WA, SR821360013WA, SR821360014WA, SR821360015WA, SR821360016WA, SR821360017WA, SR821360018WA, SR821360019WA, SR821360020WA, SR821350046WA, SR821350043WA, SR821350044WA, SR821350045WA, SR821350047WA, SR821350048WA, SR821350049WA, SR821350050WA, SR821350051WA, SR821350052WA, SR821350053WA, SR821350054WA, SR821350055WA, SR821350056WA, SR821350057WA, SR821350058WA, SR821350059WA, SR821350060WA, SR821350061WA, SR821350062WA, SR821350063WA, SR821350064WA, SR821350065WA, SR821350066WA, SR821350067WA, SR821350068WA, SR821350069WA, SR821350070WA, SR821350071WA, SR821350072WA, SR821350073WA, SR821350074WA, SR821350075WA, SR821350076WA, SR821350077WA, SR821350078WA, SR821350079WA, SR821350083WA, SR821350080WA, SR821350081WA, SR821350082WA, SR821350084WA, SR821350085WA, SR821350086WA, SR821350087WA, SR821350088WA, SR821350089WA, SR821350090WA, SR821350091WA, SR821350092WA, SR821240016WA, SR822192020WA, SR822192019WA, SR822352016WA, SR822352017WA, SR821240007WA, SR821240008WA, SR821240006WA, SR821240005WA, SR821240010WA, SR821240002WA, SR821240004WA, SR821240012WA, SR821240011WA, SR821240015WA, SR821240013WA, SR821240014WA, SR821240009WA, SR821240003WA, SR821410136WA, SR821410134WA, SR821410138WA, SR821410135WA, SR821410137WA, SR821472093WA, SR821472094WA, SR821472097WA, SR821472096WA, SR821472095WA, SR821420029WA, SR822082008WA, SR821410131WA, SR821410130WA; Model Number 6160000-005-01034529, Serial Numbers: SR822300011SA; Model Number 6160000-005-01034935, Serial Numbers: SR822372081WA, SR822372082WA, SR822372083WA; Model Number 6160000-005-01037462, Serial Numbers: SR822242066WA, SR822242067WA; Model Number 6160000-005-01040230, Serial Numbers: SR822352023WA, SR822352024WA; Model Number 6160000-005-01040493, Serial Numbers: SR822352003WA; Model Number 6160000-005-01040973, Serial Numbers: SR822372001WA, SR822372002WA, SR822372003WA, SR822372004WA, SR822372005WA, SR822372006WA, SR822372007WA, SR822372008WA; Model Number 6160000-005-01041891, Serial Numbers: SR822352025WA; Model Number 6160000-005-01044070, Serial Numbers: SR822372024WA, SR822372025WA, SR822372026WA, SR822372027WA, SR822372028WA, SR822372029WA, SR822372030WA, SR822372031WA, SR822372032WA, SR822372033WA, SR822372034WA, SR822372035WA; Model Number 6160000-005-01045083, Serial Numbers: SR822370031SA, SR822370028SA, SR822370029SA, SR822370030SA, SR822370032SA, SR822370033SA, SR822370034SA, SR822370035SA, SR822370036SA, SR822370037SA, SR822370038SA, SR822370039SA, SR822370040SA, SR822370041SA, SR822370042SA, SR822370043SA, SR822370044SA, SR822380001SA, SR822380005SA, SR822380002SA, SR822380003SA, SR822380004SA, SR822380006SA, SR822380007SA, SR822380008SA, SR822380009SA, SR822380010SA, SR822380011SA, SR822380012SA, SR822380013SA; Model Number 6160000-005-01047682, Serial Numbers: SR822352026WA; Model Number 6160000-005-01055187, Serial Numbers: SR822362001WA; Model Number 6160000-005-01055663, Serial Numbers: SR822342120WA, SR822342121WA, SR822342122WA, SR822342123WA, SR822342124WA; Model Number 6160000-005-01058503, Serial Numbers: SR822362023WA; Model Number 6160000-005-01059067, Serial Numbers: SR822322002WA, SR822322003WA; Model Number 6160000-005-01060073, Serial Numbers: SR822372009WA; Model Number 6160000-005-01065235, Serial Numbers: SR822322009WA; Model Number 6160000-005-01068737, Serial Numbers: SR822362044WA, SR822362045WA, SR822362046WA; Model Number 6160000-005-01070459, Serial Numbers: SR822342033WA, SR822342034WA, SR822342035WA, SR822342036WA, SR822342037WA, SR822342038WA, SR822342039WA, SR822342040WA, SR822342041WA, SR822342042WA, SR822342043WA, SR822342044WA, SR822342045WA, SR822342046WA, SR822342047WA, SR822342048WA, SR822342049WA, SR822342050WA, SR822342051WA, SR822342052WA, SR822342053WA, SR822342054WA, SR822342055WA, SR822342056WA, SR822342057WA, SR822342058WA, SR822342059WA, SR822342060WA, SR822342061WA, SR822342062WA, SR822342063WA; Model Number 6160000-005-01073653, Serial Numbers: SR822342210WA; Model Number 6160000-005-01075212, Serial Numbers: SR822372020WA, SR822372017WA, SR822372018WA, SR822372019WA, SR822372021WA; Model Number 6160000-005-100174, Serial Numbers: SR822202005WA, SR822202006WA, SR822202007WA, SR822202008WA, SR822202009WA, SR822202010WA, SR822202011WA, SR822192029WA, SR822192023WA, SR822192024WA, SR822192072WA, SR822192073WA, SR822202017WA, SR822192025WA, SR822192026WA, SR822192027WA, SR822192028WA, SR822192030WA, SR822192031WA, SR822192032WA, SR822192033WA, SR822192068WA, SR822192034WA, SR822192035WA, SR822192067WA, SR822192069WA, SR822192070WA, SR822192071WA, SR822192077WA, SR822192074WA, SR822192075WA, SR822192076WA, SR822192078WA, SR822192079WA, SR822192080WA, SR822192081WA, SR822192082WA, SR822202002WA, SR822192083WA, SR822192084WA, SR822202001WA, SR822202003WA, SR822202004WA, SR822202012WA, SR822202013WA, SR822202014WA, SR822202015WA, SR822202016WA; Model Number 6160000-005-100380, Serial Numbers: SR822342065WA, SR822342066WA, SR822342067WA, SR822342068WA, SR822342069WA, SR822342070WA, SR822342071WA, SR822342072WA, SR822342073WA, SR822342074WA, SR822342075WA, SR822342076WA; Model Number 6160000-005-101193, Serial Numbers: SR822342125WA; Model Number 6160000-005-101349, Serial Numbers: SR822342126WA, SR822342127WA, SR822342128WA, SR822342129WA, SR822342130WA, SR822342131WA, SR822342132WA, SR822342133WA, SR822342134WA, SR822342135WA, SR822342167WA, SR822342168WA, SR822342169WA, SR822342170WA, SR822342171WA, SR822342172WA, SR822342173WA, SR822342174WA, SR822342175WA, SR822342176WA, SR822342177WA, SR822342178WA; Model Number 6160000-005-101360, Serial Numbers: SR822352029WA, SR822352030WA, SR822352031WA, SR822352032WA, SR822352033WA, SR822352034WA, SR822362035WA, SR822362036WA, SR822362037WA; Model Number 6160000-005-101423, Serial Numbers: SR822342118WA; Model Number 6160000-005-101493, Serial Numbers: SR822202039WA, SR822202040WA, SR822202041WA, SR822202042WA, SR822202043WA, SR822202044WA, SR822202045WA; Model Number 6160000-005-101526, Serial Numbers: SR822342151WA; Model Number 6160000-005-101762, Serial Numbers: SR822261001PA, SR822261002PA, SR822261007PA, SR822261012PA, SR822261006PA, SR822271002PA, SR822281005PA, SR822271004PA, SR822281002PA, SR822281001PA, SR822281010PA, SR822271006PA, SR822261003PA, SR822261004PA, SR822281003PA, SR822261011PA, SR822271005PA, SR822271001PA, SR822261005PA, SR822261008PA, SR822261010PA; Model Number 6160000-005-101927, Serial Numbers: SR822342179WA, SR822342180WA, SR822342181WA, SR822342182WA, SR822342183WA, SR822342184WA, SR822342185WA; Model Number 6160000-005-102184, Serial Numbers: SR822342213WA, SR822342214WA; Model Number 6160000-005-704368, Serial Numbers: SR820510003WA, SR820510005WA, SR820510006WA; Model Number 6160000-005-704596, Serial Numbers: SR820510004WA; Model Number 6160000-005-704823, Serial Numbers: SR820510001WA; Model Number 6160000-005-708150, Serial Numbers: SR821040020WA, SR821040021WA, SR820470006WA, SR821010002WA, SR821010001WA, SR821040023WA, SR821040019WA, SR821040022WA, SR821030008WA, SR821040018WA, SR820470001WA, SR820470009WA, SR821040027WA, SR821040024WA, SR821040025WA, SR821040026WA, SR821040028WA, SR821040032WA, SR821040029WA, SR821040030WA, SR821040031WA, SR821040033WA, SR821040034WA, SR821040035WA, SR821040036WA, SR821040037WA; Model Number 6160000-005-711765, Serial Numbers: SR820510021WA, SR820510022WA, SR820510017WA, SR820510018WA, SR820510019WA, SR820510020WA; Model Number 6160000-005-721726, Serial Numbers: SR820490004WA, SR820490001WA, SR820490002WA, SR820490003WA, SR820490005WA; Model Number 6160000-005-722131, Serial Numbers: SR820510007WA; Model Number 6160000-005-722132, Serial Numbers: SR820510008WA, SR820510009WA, SR820510010WA, SR820510011WA, SR820510012WA, SR820510013WA, SR820510014WA, SR820510015WA, SR820510016WA; Model Number 6160000-005-723474, Serial Numbers: SR821060014WA, SR821060015WA, SR821060016WA, SR821060017WA, SR821060018WA, SR821060019WA; Model Number 6160000-005-723475, Serial Numbers: SR821060020WA, SR821060021WA, SR821060022WA, SR821060023WA, SR821060024WA, SR821060025WA, SR821080008WA, SR821080009WA, SR821080010WA, SR821080011WA, SR821080012WA, SR821080013WA, SR821080014WA, SR821080015WA, SR821080016WA, SR821080017WA; Model Number 6160000-005-725518, Serial Numbers: SR820510023WA; Model Number 6160000-005-725519, Serial Numbers: SR820510024WA, SR821110003WA, SR821110004WA, SR821110005WA; Model Number 6160000-005-726236, Serial Numbers: SR820510025WA, SR820510026WA, SR820510027WA; Model Number 6160000-005-726238, Serial Numbers: SR820510028WA; Model Number 6160000-005-727965, Serial Numbers: SR821050039WA, SR821050040WA, SR821050041WA; Model Number 6160000-005-729094, Serial Numbers: SR821040005WA; Model Number 6160000-005-742229, Serial Numbers: SR821040016WA, SR821040017WA; Model Number 6160000-005-749235, Serial Numbers: SR821040059WA, SR821040060WA; Model Number 6160000-005-749421, Serial Numbers: SR821030001WA, SR821030002WA, SR821030003WA, SR821030009WA, SR821030010WA, SR821030011WA, SR821030012WA, SR821030013WA, SR821030014WA, SR821030015WA, SR821030016WA, SR821030017WA, SR821030018WA, SR821030019WA, SR821030020WA, SR821030021WA, SR821030022WA, SR821030023WA, SR821030024WA, SR821030025WA, SR821030026WA, SR821030027WA, SR821030028WA, SR821030029WA, SR821030030WA, SR821030031WA, SR821030032WA, SR821030033WA, SR821030034WA, SR821030035WA, SR821030036WA, SR821030037WA, SR821030038WA, SR821030039WA, SR821030040WA, SR821030041WA, SR821030042WA, SR821030043WA, SR821030044WA, SR821030045WA, SR821030046WA, SR821030047WA, SR821030048WA, SR821030049WA, SR821030050WA, SR821030051WA, SR821030052WA, SR821030053WA, SR821030054WA, SR821030055WA; Model Number 6160000-005-749817, Serial Numbers: SR821040008WA, SR821040009WA, SR821040010WA, SR821040011WA, SR821040012WA, SR821040013WA, SR821040014WA, SR821040015WA; Model Number 6160000-005-750434, Serial Numbers: SR821040003WA; Model Number 6160000-005-751082, Serial Numbers: SR821030056WA; Model Number 6160000-005-753162, Serial Numbers: SR821050002WA, SR821050004WA, SR821050005WA, SR821050006WA, SR821050007WA, SR821050008WA, SR821050010WA, SR821050011WA, SR821050012WA, SR821050013WA, SR821050014WA, SR821050015WA, SR821050016WA, SR821050017WA, SR821050018WA, SR821050019WA, SR821050020WA, SR821050021WA, SR821050022WA, SR821050023WA, SR821050024WA, SR821050025WA, SR821050027WA, SR821050028WA, SR821050029WA, SR821050031WA, SR821050032WA, SR821050033WA, SR821050035WA, SR821050036WA, SR821050026WA, SR821050030WA, SR821050003WA, SR821050009WA; Model Number 6160000-005-754533, Serial Numbers: SR821050001WA; Model Number 6160000-005-754961, Serial Numbers: SR821060005WA, SR821060006WA, SR821060007WA, SR821060008WA, SR821060009WA, SR821060010WA, SR821060011WA, SR821060012WA, SR821060013WA; Model Number 6160000-005-754963, Serial Numbers: SR821060002WA, SR821060003WA, SR821060004WA; Model Number 6160000-005-755219, Serial Numbers: SR821080006WA, SR821080007WA; Model Number 6160000-005-755228, Serial Numbers: SR821050038WA; Model Number 6160000-005-757518, Serial Numbers: SR821050037WA; Model Number 6160000-005-761729, Serial Numbers: SR821060001WA, Model Number 6160000-005-762207, Serial Numbers: SR821050045WA; Model Number 6160000-005-765421, Serial Numbers: SR821100002WA; Model Number 6160000-005-766229, Serial Numbers: SR821080005WA, SR821080004WA; Model Number 6160000-005-766230, Serial Numbers: SR821080002WA, SR821080003WA; Model Number 6160000-005-771641, Serial Numbers: SR821080018WA; Model Number 6160000-005-771661, Serial Numbers: SR821160001WA; Model Number 6160000-005-778744, Serial Numbers: SR821100001WA; Model Number 6160000-005-790603, Serial Numbers: SR821130002WA, SR821130003WA, SR821130004WA, SR821160004WA, SR821160006WA, SR821160003WA, SR821160005WA, SR821130005WA, SR821130006WA, SR821160002WA,; Model Number 6160000-005-790655, Serial Numbers: SR821130007WA, SR821130008WA, SR821130009WA, SR821130010WA, SR821130011WA; Model Number 6160000-005-790747, Serial Numbers: SR821150011WA, SR821310053WA, SR822352005WA, SR821150012WA, SR821220020WA, SR821220025WA, SR821220026WA, SR821220017WA, SR821220018WA, SR821220019WA, SR821220021WA, SR821220027WA, SR821220022WA, SR821220023WA, SR821220024WA, SR821310055WA, SR821310056WA, SR821310057WA, SR821310058WA, SR822152009WA, SR822152007WA, SR822152008WA, SR821150006WA, SR821310052WA, SR821160013WA, SR821310050WA, SR821310049WA, SR822352006WA, SR821180040WA, SR821310054WA, SR821320044WA, SR821390100WA, SR821390099WA, SR822342002WA; Model Number 6160000-005-790909, Serial Numbers: SR821130001WA; Model Number 6160000-005-790959, Serial Numbers: SR821140004WA, SR821140001WA, SR821140002WA, SR821140003WA, SR821140008WA, SR821140005WA, SR821140006WA, SR821140007WA, SR821140009WA; Model Number 6160000-005-794329, Serial Numbers: SR821452071WA, SR821452072WA, SR821452073WA, SR821452075WA, SR821452076WA, SR821452077WA, SR821452080WA, SR821452067WA, SR821452068WA, SR821452069WA, SR821230011WA, SR821250014WA, SR821250011WA, SR821250012WA, SR821250013WA, SR821250015WA, SR821250016WA, SR821250017WA, SR821250018WA, SR821250019WA, SR821250020WA, SR821380010WA, SR821452074WA, SR821452078WA, SR821452079WA, SR821452070WA, SR821492029WA, SR821492030WA, SR822032010WA, SR822112027WA, SR822112024WA, SR822112025WA, SR822112026WA, SR822112028WA, SR822082058WA, SR822082039WA, SR822082046WA, SR822222043WA, SR822222042WA, SR821492031WA, SR821360323WA, SR821360322WA, SR821380009WA, SR821380012WA, SR821380011WA, SR821512012WA, SR822062033WA, SR822082048WA, SR822082043WA, SR822082044WA, SR822082047WA, SR822082051WA, SR822082053WA, SR822222037WA, SR822222034WA, SR822222035WA, SR822222036WA, SR822222038WA, SR822222039WA, SR822222041WA, SR822222040WA, SR822372040WA, SR822372041WA, SR822372042WA, SR822372043WA, SR821330068WA, SR821330066WA, SR821330067WA, SR822062020WA, SR822062019WA, SR822082050WA, SR822082049WA, SR822082040WA, SR822122008WA, SR822122005WA, SR822122006WA, SR822122007WA, SR822122009WA, SR822122010WA, SR822122011WA, SR822122012WA, SR822122013WA, SR822122014WA, SR822212006WA, SR822212004WA, SR822212005WA, SR822222033WA, SR822222078WA, SR822222076WA, SR822222077WA, SR822222079WA, SR822232042WA, SR822232040WA, SR822232041WA, SR822212007WA, SR822192018WA, SR822192015WA, SR822192016WA, SR822192017WA, SR821240019WA, SR821240018WA, SR821410129WA, SR822352251WA, SR821370004WA, SR821370002WA, SR821370001WA, SR821370003WA, SR821462092WA, SR821462089WA, SR821462090WA, SR821462091WA, SR822032017WA, SR822032014WA, SR822032015WA, SR822032016WA, SR822032019WA, SR822032018WA, SR822082056WA, SR822082054WA, SR822082055WA, SR822192008WA, SR822192005WA, SR822192006WA, SR822192007WA, SR822192004WA, SR822192003WA, SR822192009WA, SR822192013WA, SR822192010WA, SR822192011WA, SR822202023WA, SR822202022WA, SR822202021WA, SR822202019WA, SR822202020WA, SR822232036WA, SR822232035WA, SR822232039WA, SR822232037WA, SR822232038WA, SR822202018WA, SR822222051WA, SR822222048WA, SR822222049WA, SR822222050WA, SR822222047WA, SR822222044WA, SR822222045WA, SR822222046WA, SR822222053WA, SR822222052WA, SR822342001WA, SR822342003WA, SR822372067WA, SR822382009WA, SR822382007WA, SR822382008WA, SR822382005WA, SR822382004WA, SR822392013WA, SR822192012WA, SR822122004WA, SR822122001WA, SR822122002WA, SR822122003WA, SR822062022WA, SR822062021WA, SR822062023WA, SR822062024WA, SR822062025WA, SR822062026WA, SR822062027WA, SR822062028WA, SR822062029WA, SR822062030WA, SR822062031WA, SR822062032WA, SR822062034WA, SR822072001WA, SR822072002WA, SR822202036WA, SR822202024WA, SR822202025WA, SR822202026WA, SR822202027WA, SR822202028WA, SR822202029WA, SR822202030WA, SR822202031WA, SR822202032WA, SR822202033WA, SR822202034WA, SR822202038WA, SR822202035WA, SR822202037WA, SR822252001WA, SR821240023WA, SR822082052WA, SR822372010WA, SR822362004WA, SR822362002WA, SR822362003WA, SR822392012WA, SR822392011WA, SR821472024WA, SR822122023WA, SR822122021WA, SR822122022WA, SR822212015WA, SR822212010WA, SR822272001WA, SR822382006WA, SR822212014WA, SR822212013WA, SR822212008WA, SR822212009WA, SR822212011WA, SR822212012WA, SR822012001WA, SR822122018WA, SR822122015WA, SR822122016WA, SR822122017WA, SR822122019WA, SR822122020WA, SR822132004WA, SR822132001WA, SR822132002WA, SR822132003WA, SR822132005WA, SR822132006WA, SR822132007WA, SR822132008WA, SR822132009WA, SR822132010WA, SR822232048WA, SR821380007WA, SR822222074WA, SR822222071WA, SR822222072WA, SR822222073WA, SR822222075WA, SR822232049WA, SR822232033WA, SR822232032WA, SR822082057WA, SR821512036WA, SR821512034WA, SR821512035WA, SR821482001WA, SR822112023WA, SR822112022WA, SR822372076WA, SR822372075WA, SR822392015WA, SR822392014WA, SR821462088WA, SR821462086WA, SR821462087WA, SR822382087WA, SR822382084WA, SR822382085WA, SR822382086WA, SR822382088WA, SR822382089WA, SR821512009WA, SR821512006WA, SR821512007WA, SR821512008WA, SR821512010WA, SR821512011WA, SR821502034WA, SR821240017WA, SR821250008WA, SR822372071WA, SR822372068WA, SR822372069WA, SR822372070WA, SR822372072WA, SR822372023WA, SR822372022WA, SR822192058WA, SR822192055WA, SR822192056WA, SR822192057WA, SR822192059WA, SR822192060WA, SR822192061WA, SR822192062WA, SR822192063WA, SR822192064WA, SR822192065WA, SR822192066WA, SR822192050WA, SR822192047WA, SR822192048WA, SR822192049WA, SR822192051WA, SR822192052WA, SR822192053WA, SR822192054WA, SR821320012WA, SR821330003WA, SR821330001WA, SR821330002WA, SR821430046WA, SR821472009WA, SR821482067WA, SR821482065WA, SR821482066WA, SR821492028WA, SR821492026WA, SR821492027WA, SR821512023WA, SR821512018WA, SR821512019WA, SR821512020WA, SR821512021WA, SR821512022WA, SR821512024WA, SR821512025WA, SR821512026WA, SR821512027WA, SR821512028WA, SR821512029WA, SR821512030WA, SR821512031WA, SR821512032WA, SR821512033WA, SR821512040WA, SR821512037WA, SR821512038WA, SR821512039WA, SR821512041WA, SR821512042WA, SR821512043WA, SR821512046WA, SR821512044WA, SR821512045WA, SR822012008WA, SR822012005WA, SR822012006WA, SR822012007WA, SR822012009WA, SR822012010WA, SR822012011WA, SR822012012WA, SR822012013WA, SR822012014WA, SR822012015WA, SR822012004WA, SR822012002WA, SR822012003WA, SR822222020WA, SR822222017WA, SR822222018WA, SR822222019WA, SR822222021WA, SR822222022WA, SR822222023WA, SR822222024WA, SR822222025WA, SR822222026WA, SR822222027WA, SR822222028WA, SR822222029WA, SR822222030WA, SR822222031WA, SR822222032WA, SR822222004WA, SR822222001WA, SR822222002WA, SR822222003WA, SR822222005WA, SR822222006WA, SR822222007WA, SR822222008WA, SR822222009WA, SR822222013WA, SR822222010WA, SR822222011WA, SR822222012WA, SR822222014WA, SR822222015WA, SR822222016WA, SR822232034WA, SR822252003WA, SR822252002WA, SR822372047WA, SR822372044WA, SR822372045WA, SR822372046WA, SR822372078WA, SR822372077WA, SR822232031WA, SR822242001WA, SR822372048WA, SR821320043WA, SR821512005WA, SR822082061WA, SR822082059WA, SR822082060WA, SR822232053WA, SR822232050WA, SR822232051WA, SR822232052WA, SR822232054WA, SR822232055WA, SR822232056WA, SR822232057WA, SR822232058WA, SR822232059WA, SR822232060WA, SR822232061WA, SR822232062WA, SR821270053WA, SR821270052WA, SR822362050WA, SR822362047WA, SR822362048WA, SR822362049WA, SR822362051WA, SR821250010WA, SR821250009WA, SR821430015WA, SR821430014WA, SR82208

Quantity Affected: 3348 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

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-0733-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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