GE Medical Systems recalls certain B105P Patient Monitors with E-module slot that may display inaccurate CO2 readings when used in locations not at or near sea level. This could affect medical monitoring accuracy.
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 Medical Systems is recalling specific B105P Patient Monitors that may show inaccurate CO2 measurements when used in areas not at or near sea level. This could lead to incorrect medical readings if the monitor is used in such locations.
The patient monitor may display incorrect CO2 values when using 'mmHg' or 'kPa' as the unit for CO2 measurement in areas not at or near sea level. This could lead to inaccurate medical readings if the monitor is used in such locations.
Healthcare facilities and patients using the recalled patient monitors in locations not at or near sea level. The risk is low as the issue only affects CO2 measurement accuracy, not safety.
Check for the model number 6160000-001-XXXXXX and serial numbers listed in the recall notice. The specific serial numbers are provided in the recall record.
Ensure the CO2 measurement unit is set to 'atm' or 'kPa' for locations at or near sea level to avoid inaccurate readings.
GE Medical Systems has identified that certain B105P Patient Monitors may display inaccurate CO2 measurements when using 'mmHg' or 'kPa' as the unit in locations not at or near sea level.
No, you can continue using the monitor but ensure it is set to the correct unit for your location to avoid inaccurate readings.
Check the model number and serial numbers listed in the recall notice to see if your monitor is included.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0729-2023 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-0729-2023 from GE Medical Systems. 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.