Recall archive / FDA device enforcement
B105M Patient Monitor, REF 6160000-003 — FDA record Z-0731-2023
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
- B105M Patient Monitor, REF 6160000-003
- 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
- 3905 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0731-2023
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 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: SR62112005... |
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.