FDA Device recall Z-0729-2023
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX 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-0729-2023 |
| 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
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
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 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA,…UDI/DI 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA, SR422332027WA, SR422332029WA, SR422332030WA, SR422332031WA, SR422332032WA, SR422332049WA, SR422332050WA, SR422332051WA, SR422332052WA, SR422332053WA, SR422332054WA, SR422332055WA, SR422332056WA, SR422332057WA, SR422332061WA, SR422332058WA, SR422332059WA, SR422332060WA, SR422332062WA, SR422332063WA, SR422332064WA, SR422332047WA, SR422332044WA, SR422332045WA, SR422332046WA, SR422332048WA, SR422332033WA, SR422332034WA, SR422332035WA, SR422332036WA, SR422332037WA, SR422332038WA, SR422332039WA, SR422332040WA, SR422332041WA, SR422332042WA, SR422332043WA, SR422332017WA, SR422332018WA, SR422332019WA, SR422332020WA, SR422332021WA, SR422332022WA, SR422332023WA, SR422332024WA, SR422332065WA, SR422332066WA, SR422332067WA, SR422332068WA, SR422332069WA, SR422332070WA, SR422332071WA, SR422332072WA, SR422332081WA, SR422332082WA, SR422332083WA, SR422332084WA, SR422332085WA, SR422332086 |
|---|
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-0729-2023%22
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