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GE Medical Systems, LLC recalls B125M Patient Monitor, REF 6160000-004-XXXXXX
Recalled December 28, 2022 · FDA recall Z-0732-2023 · GE Medical Systems
Hazard
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. · FDA Class II
Units
5962
Sold at
Worldwide distribution.
Description
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.
Product
B125M Patient Monitor, REF 6160000-004-XXXXXX
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →