FDA recall Z-0733-2023

Product

B125M Patient Monitor, REF 6160000-005-XXXXXXX

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-11-16

Report date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2023