GE Healthcare recalls B125M Patient Monitors with specific serial numbers that may display inaccurate CO2 measurements when used at altitudes above sea level. This could lead to incorrect patient monitoring readings. Affected units include models 6160000-004 with serial numbers listed in the recall notice.
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 B125M Patient Monitors that may display inaccurate CO2 measurements when used at locations not at or near sea level. This could lead to incorrect patient monitoring readings if the monitor is used in high-altitude areas. The recall does not involve immediate safety risks but requires users to be aware of the altitude setting.
The monitor's CO2 measurement unit (mmHg or kPa) can display inaccurate values when used at altitudes above sea level. This is due to the monitor's calibration being intended for sea-level environments only. High-altitude locations have different atmospheric pressure, which affects the accuracy of the CO2 readings.
Healthcare providers using the B125M Patient Monitors with specific serial numbers listed in the recall notice. Patients in high-altitude locations using these monitors may experience inaccurate CO2 readings.
Check if your B125M Patient Monitor has the model number 6160000-004 and one of the listed serial numbers in the recall notice. The recall includes specific serial numbers across multiple model variants.
Verify your monitor's model number (6160000-004) and serial number against the list provided in the recall notice.
GE Healthcare has identified that certain B125M Patient Monitors may display inaccurate CO2 measurements when used at altitudes above sea level due to calibration for sea-level environments only.
No action is required if you are at or near sea level, as the monitor's calibration is appropriate for these conditions.
Check your monitor's model number (6160000-004) and serial number against the list of affected units provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0732-2023 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0732-2023 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.
