B105M Patient Monitor — Class II medical device recall Z-0731-2023
Ongoing recall by GE Medical Systems, LLC, reported 2022-12-28. GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit
| Recall number | Z-0731-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-11-16 |
| Classified | 2022-12-19 |
| Reported by FDA | 2022-12-28 |
| Quantity | 3,905 units |
| UPC / GTIN / UDI-DI | 00840682146708 |
| Serial numbers | 4SA, SR62, SR620470001WA, SR620470002WA, SR620470003WA, SR620470004WA, SR620470005WA, SR620490001WA, SR620490002WA, SR620490003WA, SR620490004WA, SR620490005WA, SR620490006WA, SR620490009WA, SR620490010WA, SR620490011WA, SR620490012WA, SR620490013WA, SR620490014WA, SR620490015WA, SR620490016WA, SR620490017WA, SR620490018WA, SR620490019WA, SR620490020WA and 475 more |
| Model numbers | 6160000-003, 6160000-003-01034677, 6160000-003-01036673, 6160000-003-01045082, 6160000-003-01047272, 6160000-003-01054632, 6160000-003-01054644, 6160000-003-01054806, 6160000-003-01056201, 6160000-003-01058032, 6160000-003-01058330, 6160000-003-01059142, 6160000-003-01060133, 6160000-003-01062599, 6160000-003-01079753, 6160000-003-01086095, 6160000-003-100174, 6160000-003-100318, 6160000-003-100392, 6160000-003-100536, 6160000-003-100708, 6160000-003-100729, 6160000-003-100767, 6160000-003-101032, 6160000-003-101186 and 151 more |
Product
B105M Patient Monitor, REF 6160000-003
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0731-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.