GE Healthcare recalls CARESCAPE Respiratory Module E-sCAiO units with potential up to 50% error in End Tidal Oxygen and Fraction of Inspired Oxygen readings. Affected units have specific serial numbers and lot codes. No action is required for safety, but users should verify readings.
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-sCAiO devices due to potential up to 50% measurement errors in oxygen levels. This could lead to incorrect patient oxygen monitoring, though the risk of serious harm is not specified 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. This could lead to improper oxygen monitoring for patients, though the recall does not indicate a risk of serious injury.
Healthcare providers using the recalled respiratory modules may be affected. Patients using these devices could experience inaccurate oxygen readings, but the recall does not specify a risk of serious injury.
Check for the specific serial numbers and lot codes listed in the recall notice. Affected units include models with SGV19240073HA through SGV19300042HA, with specific serial numbers and lot codes provided in the recall list.
Check the device's serial number and lot code against the list provided in the recall notice.
The recall does not specify a risk of serious injury. The hazard is potential measurement error, but no harm is mentioned.
No immediate action is required. The recall does not state that the device should be stopped or discarded.
Check the device's serial number and lot code against the list of affected units provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0756-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0756-2020 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.
