GE Healthcare recalls CARESCAPE Respiratory Module E-sCAiOVE units with potential up to 50% error in oxygen measurements, which could lead to unsafe patient monitoring. 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-sCAiOVE devices because they may display incorrect oxygen levels, potentially causing dangerous measurement errors. This could lead to improper patient care if the device is used without correction.
The device may show oxygen levels up to 50% higher or lower than actual values. This error could lead to incorrect treatment decisions, such as administering too much or too little oxygen, which might harm patients.
Healthcare facilities using the recalled CARESCAPE Respiratory Module E-sCAiOVE units are most at risk. Patients receiving oxygen therapy through these devices could be affected if the measurements are inaccurate.
Check for serial numbers starting with SGV19295006HA, SGV19255001HA, SGV19295019HA, SGV19255002HA, SGV19255004HA, SGV19255010HA, SGV19255017HA, SGV19255019HA, SGV16385015HA, or SGV15285005HA. Units manufactured on or after specific dates are also affected.
Look for the serial number on the device label, which starts with SGV followed by specific numbers.
The device may display oxygen levels up to 50% higher or lower than actual values, which could lead to incorrect patient treatment.
Check the serial number on the device label to see if it matches the affected units listed in the recall notice.
The recall notice does not mention a remedy or fix for this issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0759-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0759-2020 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.
