GE Medical Systems, LLC: B125M Patient Monitor, REF 6160000-004-XXXXXX

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.

Details from the source

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. Quantity: 5962 Lot/code info: UDI/DI 00840682146715: Model Number 6160000-004, Serial Numbers: SR722210034SA, SR722210037SA, SR722210030SA, SR722210040SA, SR722210042SA, SR722210039SA, SR722210041SA, SR722220001SA, SR722210029SA, SR722220004SA, SR722220005SA, SR722210031SA, SR722210032SA, SR722220002SA, SR722210035SA, SR722210038SA, SR722210033SA, SR722210028SA, SR722220003SA, SR722210036SA, SR722180001SA, SR722090020WA, SR722090001WA, SR722090013WA, SR722090010WA, SR722090019WA, SR722090024WA, SR722090006WA, SR722090018WA, SR722090025WA, SR722090012WA, SR722090022WA, SR722090021WA, SR722090008WA, SR722090015WA, SR722090009WA, SR722090011WA, SR722090005WA, SR722090004WA, SR722090023WA, SR722090017WA, SR722090002WA, SR722090016WA, SR722090014WA, SR722090007WA, SR722090003WA, SR722340009SA, SR722260035SA, SR722260034SA, SR722260040SA, SR722260029SA, SR722260038SA, SR722260041SA, SR722260032SA, SR722260042SA, SR722260037SA, SR722260026SA, SR722260025SA, SR722260028SA, SR722260024SA, SR722260030SA, SR722260031SA, SR722260033SA, SR722260039SA, SR722260036SA, SR722260027SA, SR722340010SA, SR722340016SA, SR722340011SA, SR722340013SA, SR722340157SA, SR722340012SA, SR722340017SA, SR722210023SA, SR722210010SA, SR722210011SA, SR722210025SA, SR722210019SA, SR722210012SA, SR722210008SA, SR722210013SA, SR722210018SA, SR722210021SA, SR722210014SA, SR722210016SA, SR722210024SA, SR722210026SA, SR722210017SA, SR722210015SA, SR722210009SA, SR722210020SA, SR722210022SA, SR722210007SA, SR722210027SA, SR722300002SA, SR72233006

UPC codes

00840682146715

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.