GE Healthcare recalls CARESCAPE Respiratory Module E-sCO units with potential up to 50% error in End Tidal Oxygen and Fraction of Inspired Oxygen readings. Affected units have specific serial numbers and manufacturing lots.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
GE Healthcare is recalling certain CARESCAPE Respiratory Module E-sCO devices because they may display incorrect End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values, potentially causing up to 50% measurement error. This could lead to improper oxygen therapy decisions for patients.
The device may show incorrect oxygen levels, which could lead to under- or over-administration of oxygen. This might cause patient harm if healthcare providers rely on the inaccurate readings to adjust oxygen therapy.
Healthcare facilities using the recalled CARESCAPE Respiratory Module E-sCO devices are most at risk. Patients receiving oxygen therapy through these devices could be affected if the measurements are inaccurate.
Check for the specific serial numbers and manufacturing lots listed in the recall notice. Affected units have the following identifiers: SGV19241006HA, SGV19241003HA, SGV19241044HA, and other combinations ending with 11190614, 11190619, or 11190711.
Look for the serial number on the device label, which should match one of the listed identifiers in the recall notice.
The device may display incorrect End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values, potentially causing up to 50% measurement error.
Check the serial number on your device label. Affected units have specific identifiers listed in the recall notice, such as SGV19241006HA or SGV19241003HA.
The recall notice does not specify a remedy, so contact GE Healthcare for further instructions.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0754-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0754-2020 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.
