Recall archive / FDA device enforcement
B125M Patient Monitor, REF 6160000-005-XXXXXXX — FDA record Z-0733-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- B125M Patient Monitor, REF 6160000-005-XXXXXXX
- 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 for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 3348 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0733-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, SR82135... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Nov 16, 2022
- Center classification date
- Dec 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.