Product Wiki · Recalls · Health Canada — Medical Devices

AISYS CS2 ANESTHESIA MACHINE MAIN UNIT (2016-02-18) — recall 54988

Health Canada — Medical Devices · Canada · 2016-03-04 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54988
Date of alert
2016-03-04
Country / jurisdiction
Canada
Risk level
Type II
Risk 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 involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. Delivery of this momentary bolus of anesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable pediatric patients when 21% oxygen (air only) is used. There have been no injuries reported as a result of this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aisys-cs2-anesthesia-machine-m

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