GE Healthcare recalls CARESCAPE Respiratory Module E-sCAiOV units with potential up to 50% error in oxygen measurements. Affected units have specific serial numbers and lot codes.
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-sCAiOV devices because they may show incorrect oxygen levels, which could lead to dangerous measurement errors. This affects medical devices used in hospitals for patient 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 shown to healthcare providers, potentially causing unsafe patient management decisions.
Healthcare facilities using the recalled respiratory modules are most at risk. Patients receiving oxygen monitoring via these devices could be affected if the measurements are inaccurate.
Check for the specific serial numbers and lot codes listed in the recall notice. Affected units include those with the serial numbers starting with SGV19283064HA, SGV19283042HA, SGV19243024HA, and other combinations listed in the recall.
Look for the serial number on the device or its packaging to confirm if it matches the listed serial numbers in the recall notice.
The recall is due to potential up to 50% error in End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) measurements, which could lead to incorrect patient oxygen levels being displayed.
Check the device's serial number against the list of affected units provided in the recall notice, which includes specific combinations like SGV19283064HA and SGV19283042HA.
Contact GE Healthcare directly to confirm if your device is affected and follow their instructions for next steps.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0757-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0757-2020 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.
