Events

Recall of AISYS CS2 ANESTHESIA MACHINE MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64154
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    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.

Device

AISYS CS2 ANESTHESIA MACHINE MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)