B125M Patient Monitor — Class II medical device recall Z-0732-2023
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-0732-2023 |
|---|---|
| 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 | 5,962 |
| UPC / GTIN / UDI-DI | 00840682146715 |
| Serial numbers | SR720470001WA, SR720470002WA, SR720470003WA, SR720470004WA, SR720470005WA, SR720470006WA, SR720470007WA, SR720480001WA, SR720480002WA, SR720480003WA, SR720480004WA, SR720480005WA, SR720480006WA, SR720480007WA, SR720480008WA, SR720480009WA, SR720480010WA, SR720480011WA, SR720480012WA, SR720480013WA, SR720480014WA, SR720480015WA, SR720480016WA, SR720480017WA, SR720480018WA and 475 more |
| Model numbers | 6160000-004, 6160000-004-01033170, 6160000-004-01034790, 6160000-004-01036427, 6160000-004-01036518, 6160000-004-01036836, 6160000-004-01040730, 6160000-004-01040802, 6160000-004-01051951, 6160000-004-01054042, 6160000-004-01054990, 6160000-004-01055026, 6160000-004-01055524, 6160000-004-01058339, 6160000-004-01059539, 6160000-004-01064964, 6160000-004-01069980, 6160000-004-01073870, 6160000-004-01074082, 6160000-004-01074097, 6160000-004-01074597, 6160000-004-01075297, 6160000-004-01075302, 6160000-004-01075671, 6160000-004-01075962 and 334 more |
Product
B125M Patient Monitor, REF 6160000-004-XXXXXX
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-0732-2023. 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.