GE Healthcare recalls B125P Patient Monitors with E-module slot option that may display inaccurate CO2 readings when used above sea level. Units sold with 'mmHg' or 'kPa' units for CO2 measurement are affected. No remedy specified.
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.
GE Healthcare is recalling certain B125P Patient Monitors with E-module slot option that may display inaccurate CO2 measurements when used at elevations above sea level. This happens if the monitor is set to use 'mmHg' or 'kPa' as the unit for CO2 measurement. The issue does not cause injury but could lead to incorrect medical decisions.
The monitor may display incorrect CO2 values when used at locations not at or near sea level. This occurs when the device is set to use 'mmHg' or 'kPa' as the unit for CO2 measurement. The inaccuracy could lead to incorrect medical decisions if healthcare providers rely on the displayed values.
Healthcare providers using the recalled patient monitors with E-module slot option. Patients receiving care from these monitors may be at risk if the CO2 readings are inaccurate due to elevation.
Check if your monitor has a model number starting with 6160000-002 and serial numbers listed in the provided range. The device may be labeled with 'mmHg' or 'kPa' for CO2 measurement units.
Verify if your monitor uses 'mmHg' or 'kPa' as the unit for CO2 measurement. If so, it may be affected.
No. The recall does not require stopping use, but you should check if your monitor uses 'mmHg' or 'kPa' for CO2 measurement. If it does, you may need to adjust settings or contact GE Healthcare.
Check if your monitor has a model number starting with 6160000-002 and serial numbers listed in the provided range. Also, verify if it uses 'mmHg' or 'kPa' for CO2 measurement units.
The recall does not specify a remedy. You may need to adjust the monitor settings or contact GE Healthcare for further assistance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0730-2023 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0730-2023 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
