FDA Device recall Z-0733-2023
B125M Patient Monitor, REF 6160000-005-XXXXXXX
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of B125M Patient Monitor, REF 6160000-005-XXXXXXX by Ge Medical Systems, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0733-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-16 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Medical Systems |
| Distribution | n/a |
Product
B125M Patient Monitor, REF 6160000-005-XXXXXXX
Reason
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.
Identifiers
| code_info | UDI/DI 00840682146791: Model Number 6160000-005, Serial Numbers: SR821512013WA, SR821512014WA, SR821512017WA, SR8215…UDI/DI 00840682146791: Model Number 6160000-005, Serial Numbers: SR821512013WA, SR821512014WA, SR821512017WA, SR821512016WA, SR821512015WA, SR821430047WA, SR821430049WA, SR821430048WA, SR821430050WA, SR821410068WA, SR821170021WA, SR822062011WA, SR821260059WA, SR822072018WA, SR822072016WA, SR822072015WA, SR822072022WA, SR822072021WA, SR822072020WA, SR822072019WA, SR822072017WA, SR822072014WA, SR822072013WA, SR821170023WA, SR821180036WA, SR821180037WA, SR821180035WA, SR821180038WA, SR821180039WA, SR821210003WA, SR821210001WA, SR821210002WA, SR821210004WA, SR821210005WA, SR821210006WA, SR821210007WA, SR821210008WA, SR821210009WA, SR821210010WA, SR821250021WA, SR821250027WA, SR821250022WA, SR821250023WA, SR821250024WA, SR821250025WA, SR821260010WA, SR822072012WA, SR822072011WA, SR822072003WA, SR822072005WA, SR822072010WA, SR822072006WA, SR822072009WA, SR822072008WA, SR822072007WA, SR822072004WA, SR821260012WA, SR822062004WA, SR822062005WA, SR822062006WA, SR822290015SA, SR822300010SA, SR |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2023%22
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