Product Wiki · Recalls · Health Canada — Medical Devices

CARESCAPE Respiratory Modules (2019-09-30) — recall 60054

Health Canada — Medical Devices · Canada · 2019-11-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60054
Date of alert
2019-11-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical 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. This issue can occur in the O2 sensor of the CARESCAPE Respiratory Modules and Airway Gas Options.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/carescape-respiratory-modules-

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