FDA-Device2022-12-28Class II
B125M Patient Monitor, REF 6160000-005-XXXXXXX
GE Medical Systems, LLC
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.
Sold states
Worldwide distribution.
Affected count
3348 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
B125M Patient Monitor, REF 6160000-005-XXXXXXX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2023Don't want to check this manually?
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