GE Healthcare recalls CARESCAPE Respiratory Module E-sCAiOE units with potential up to 50% error in oxygen measurements. 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-sCAiOE devices because they may show incorrect oxygen levels, which could lead to dangerous under- or overestimation of a patient's oxygen status. This recall affects medical devices used in hospitals and critical care settings.
The device may display End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values with up to 50% error. This could cause healthcare providers to misjudge a patient's oxygen levels, potentially leading to inadequate treatment or unnecessary interventions.
Healthcare facilities using the recalled respiratory modules are most at risk, particularly those in critical care where accurate oxygen monitoring is essential for patient safety.
Check for the specific serial numbers listed in the recall notice, which include combinations like SGV19254028HA followed by a 12-digit number and a date. The affected units were manufactured between August 2016 and July 2019.
Look for the serial number on the device label, which should match the specific patterns listed in the recall notice.
The recalled device is the CARESCAPE Respiratory Module E-sCAiOE with specific serial numbers listed in the recall notice.
Check the serial number on your device label. Affected units have specific patterns like SGV19254028HA followed by a 12-digit number and a date, as listed in the recall notice.
The recall notice does not specify a remedy or replacement option.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0758-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0758-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
