FDA Device recall Z-0730-2023
B125P Patient Monitor (with E-module slot option), REF 6160000-002
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of B125P Patient Monitor (with E-module slot option), REF 6160000-002 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-0730-2023 |
| 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
B125P Patient Monitor (with E-module slot option), REF 6160000-002
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 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, S…UDI/DI 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, SR522350003WA, SR522350005WA, SR522350006WA, SR522350007WA, SR522350008WA, SR522350009WA, SR522350010WA, SR522350011WA, SR522350012WA, SR522350013WA, SR522350014WA, SR522350015WA, SR522350016WA, SR522350017WA, SR522350018WA, SR522350019WA, SR522350020WA, SR522350021WA, SR522350047WA, SR522350048WA, SR522350049WA, SR522350050WA, SR522350088WA, SR522350051WA, SR522350053WA, SR522350054WA, SR522350055WA, SR522350087WA, SR522350089WA, SR522350090WA, SR522350091WA, SR522350092WA, SR522350093WA, SR522350094WA, SR522350095WA, SR522350096WA, SR522350097WA, SR522350098WA, SR522350168WA, SR522350165WA, SR522350166WA, SR522350167WA, SR522350169WA, SR522350170WA, SR522350171WA, SR522350172WA, SR522350173WA, SR522350174WA, SR522350175WA, SR522350176WA, SR522350177WA, SR522350178WA, SR522350179WA, SR522350183WA, SR522350180WA, SR522350181WA, SR522350182WA, SR522350160WA, SR522350161W |
|---|
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-0730-2023%22
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