B125P Patient Monitor — Class II medical device recall Z-0730-2023
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-0730-2023 |
|---|---|
| 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 | 388 units |
| UPC / GTIN / UDI-DI | 00840682147224 |
| Serial numbers | SR521040001WA, SR521040002WA, SR521040003WA, SR521040004WA, SR521040006WA, SR521040007WA, SR521040008WA, SR521040009WA, SR521040010WA, SR521040011WA, SR521040012WA, SR521040013WA, SR521040014WA, SR521040015WA, SR521040016WA, SR521040017WA, SR521040018WA, SR521040019WA, SR521040020WA, SR521040021WA, SR521040022WA, SR521040023WA, SR521050001WA, SR521050002WA, SR521050003WA and 475 more |
| Model numbers | 6160000-002, 6160000-002-100174, 6160000-002-100767, 6160000-002-101962, 6160000-002-753161, 6160000-002-767129, 6160000-002-790743, 6160000-002-791942, 6160000-002-795077, 6160000-002-807391, 6160000-002-811089, 6160000-002-813390, 6160000-002-815200, 6160000-002-816411, 6160000-002-818359, 6160000-002-832284, 6160000-002-841595, 6160000-002-849738, 6160000-002-870236, 6160000-002-870818, 6160000-002-874089, 6160000-002-874722, 6160000-002-905758, 6160000-002-906055, 6160000-002-912058 and 7 more |
Product
B125P Patient Monitor (with E-module slot option), REF 6160000-002
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-0730-2023. 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.