B125M Patient Monitor — Class II medical device recall Z-0733-2023
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-0733-2023 |
|---|---|
| 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 | 3,348 units |
| UPC / GTIN / UDI-DI | 00840682146791 |
| Serial numbers | SR820470001WA, SR820470006WA, SR820470009WA, SR820490001WA, SR820490002WA, SR820490003WA, SR820490004WA, SR820490005WA, SR820510001WA, SR820510003WA, SR820510004WA, SR820510005WA, SR820510006WA, SR820510007WA, SR820510008WA, SR820510009WA, SR820510010WA, SR820510011WA, SR820510012WA, SR820510013WA, SR820510014WA, SR820510015WA, SR820510016WA, SR820510017WA, SR820510018WA and 475 more |
| Model numbers | 6160000-005, 6160000-005-01034529, 6160000-005-01034935, 6160000-005-01037462, 6160000-005-01040230, 6160000-005-01040493, 6160000-005-01040973, 6160000-005-01041891, 6160000-005-01044070, 6160000-005-01045083, 6160000-005-01047682, 6160000-005-01055187, 6160000-005-01055663, 6160000-005-01058503, 6160000-005-01059067, 6160000-005-01060073, 6160000-005-01065235, 6160000-005-01068737, 6160000-005-01070459, 6160000-005-01073653, 6160000-005-01075212, 6160000-005-100174, 6160000-005-100380, 6160000-005-101193, 6160000-005-101349 and 230 more |
Product
B125M Patient Monitor, REF 6160000-005-XXXXXXX
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-0733-2023. 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.