B105P Patient Monitor — Class II medical device recall Z-0729-2023
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-0729-2023 |
|---|---|
| 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 | 826 devices |
| UPC / GTIN / UDI-DI | 00840682147217 |
| Serial numbers | SR420510001WA, SR420510002WA, SR421040002WA, SR421050005WA, SR421050006WA, SR421050007WA, SR421050008WA, SR421050009WA, SR421060001WA, SR421060002WA, SR421060003WA, SR421060004WA, SR421070001WA, SR421070002WA, SR421100001WA, SR421120054WA, SR421120055WA, SR421120056WA, SR421120057WA, SR421120058WA, SR421120059WA, SR421120060WA, SR421120061WA, SR421120062WA, SR421120063WA and 475 more |
| Model numbers | 6160000-001-100174, 6160000-001-100728, 6160000-001-726232, 6160000-001-726248, 6160000-001-737890, 6160000-001-765412, 6160000-001-767955, 6160000-001-771434, 6160000-001-787700, 6160000-001-788679, 6160000-001-791943, 6160000-001-794786, 6160000-001-799233, 6160000-001-802266, 6160000-001-803246, 6160000-001-830726, 6160000-001-839141, 6160000-001-848493, 6160000-001-848921, 6160000-001-861261, 6160000-001-906100, 6160000-001-906386, 6160000-001-925411, 6160000-001-928665, 6160000-001-954478 and 1 more |
Product
B105P Patient Monitor (with E-module slot option), REF 6160000-001-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-0729-2023. 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.