GE Healthcare recalls CARESCAPE Respiratory Module E-sCOVX units with potential up to 50% error in oxygen measurements, which could affect patient safety. Affected units have specific serial numbers and manufacturing dates.
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-sCOVX devices because they may show incorrect oxygen levels, risking patient safety. This could lead to serious health issues if the device is used without proper monitoring.
The device may display end tidal oxygen (EtO2) and fraction of inspired oxygen (FiO2) values with up to 50% error. This could lead to incorrect oxygen levels being reported, potentially causing patient harm if the device is used without proper monitoring.
Healthcare facilities using the recalled respiratory modules are most at risk. Patients receiving oxygen therapy through these devices could be affected if the measurements are inaccurate.
Check for the serial numbers: SGV19276034HA 010084068210428921SGV19276034HA11190702, SGV19266019HA 010084068210428921SGV19266019HA11190626, or SGV14404046HA. These units were manufactured on specific dates.
Look for the serial numbers listed in the recall notice to confirm if your device is affected.
The device may display incorrect oxygen measurements, which could lead to serious patient safety risks.
Check for the specific serial numbers listed in the recall notice: SGV19276034HA 010084068210428921SGV19276034HA11190702, SGV19266019HA 010084068210428921SGV19266019HA11190626, or SGV14404046HA.
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-0755-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0755-2020 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.
