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[Recalled] CARESCAPE Respiratory Module E-sCAiO — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values… | FDA 2019-09-27

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCARESCAPE Respiratory Module E-sCAiO
Brand / manufacturerGE Healthcare, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0756-2020
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date27 September 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from GE Healthcare, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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