Product Wiki · Recalls · Health Canada — Medical Devices

Carestation 620 and 650 (2017-05-02) — recall 56633

Health Canada — Medical Devices · Canada · 2017-06-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56633
Date of alert
2017-06-12
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: GE Healthcare has recently become aware of a potential safety issue with the CareStation 620, 650 and 650C. An incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the CareStation 600 series systems. This incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (CO2) absorbent material and could result in unintended elevated inspired levels of co2 (FICO2), which could lead to hypercarbia.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/carestation-620-and-650-2017-0

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