FDA Device recall Z-0731-2023

B105M Patient Monitor, REF 6160000-003

FDA Device
Class II
ongoing
Published 2022-12-28

On 2022-12-28 the FDA classified a Class II recall of B105M Patient Monitor, REF 6160000-003 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-0731-2023
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

B105M Patient Monitor, REF 6160000-003

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 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR6220… UDI/DI 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR622092005WA, SR622092028WA, SR622092001WA, SR622092007WA, SR622092027WA, SR622092010WA, SR622092024WA, SR622092022WA, SR622092006WA, SR622092020WA, SR622092030WA, SR622092013WA, SR622092019WA, SR622092009WA, SR622092016WA, SR622092018WA, SR622092023WA, SR622092032WA, SR622092029WA, SR622092033WA, SR622092015WA, SR622092008WA, SR622092031WA, SR622092011WA, SR622092002WA, SR622092026WA, SR622092003WA, SR622092034WA, SR622092014WA, SR622092021WA, SR622092017WA, SR622092004WA, SR622092035WA, SR622092025WA, SR622360008SA, SR622360009SA, SR622360001SA, SR622360010SA, SR622360006SA, SR622360003SA, SR622360004SA, SR622360002SA, SR622360005SA, SR622360007SA; Model Number 6160000-003-01034677, Serial Numbers: SR622322001WA, SR622322002WA, SR622322003WA, SR622322004WA, SR622322005WA, SR622322006WA, SR622322007WA, SR622322008WA, SR622322009WA, SR622322010WA, SR622322011WA, SR6223220

code_info

UDI/DI 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR6220…

UDI/DI 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR622092005WA, SR622092028WA, SR622092001WA, SR622092007WA, SR622092027WA, SR622092010WA, SR622092024WA, SR622092022WA, SR622092006WA, SR622092020WA, SR622092030WA, SR622092013WA, SR622092019WA, SR622092009WA, SR622092016WA, SR622092018WA, SR622092023WA, SR622092032WA, SR622092029WA, SR622092033WA, SR622092015WA, SR622092008WA, SR622092031WA, SR622092011WA, SR622092002WA, SR622092026WA, SR622092003WA, SR622092034WA, SR622092014WA, SR622092021WA, SR622092017WA, SR622092004WA, SR622092035WA, SR622092025WA, SR622360008SA, SR622360009SA, SR622360001SA, SR622360010SA, SR622360006SA, SR622360003SA, SR622360004SA, SR622360002SA, SR622360005SA, SR622360007SA; Model Number 6160000-003-01034677, Serial Numbers: SR622322001WA, SR622322002WA, SR622322003WA, SR622322004WA, SR622322005WA, SR622322006WA, SR622322007WA, SR622322008WA, SR622322009WA, SR622322010WA, SR622322011WA, SR6223220

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-0731-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.