Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0756-2020 — CARESCAPE Respiratory Module E-sCAiO

U.S. FDA — Device Enforcement · United States · 2019-09-27 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0756-2020
Date of alert
2019-09-27
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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