GE Healthcare recalls B105M Patient Monitors with specific model numbers and serials that may display inaccurate CO2 measurements when used at elevations above sea level due to unit conversion errors.
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 B105M Patient Monitors that may display inaccurate CO2 measurements when used in locations not at or near sea level. This happens when the monitor uses 'mmHg' or 'kPa' as the unit for CO2 measurement. The issue does not cause injury but could lead to incorrect readings in high-altitude settings.
The monitor's CO2 measurement system uses 'mmHg' or 'kPa' units but calculates values based on sea level standards. At higher elevations, atmospheric pressure differs, causing the displayed CO2 values to be inaccurate. This could lead to incorrect clinical decisions in high-altitude settings.
Healthcare providers using these specific B105M Patient Monitors with model numbers and serials listed in the recall notice are affected. Patients at high elevations may experience inaccurate CO2 readings.
Check if your monitor has model number 6160000-003 with the listed serial numbers or model numbers (e.g., 6160000-003-01034677). The recall includes specific serial numbers and model variants.
Verify your monitor's model number and serial numbers against the list provided in the recall notice.
If your monitor is listed, contact GE Healthcare for further instructions or to confirm if a correction is needed.
GE Healthcare has identified that certain B105M Patient Monitors may display inaccurate CO2 measurements when used at elevations above sea level due to unit conversion errors.
No, you do not need to stop using the monitor. The issue only affects CO2 readings at high elevations, not general safety.
Check your monitor's model number and serial numbers against the list 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-0731-2023 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0731-2023 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.
