Events

Recall of CARESTATION 650

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
    66825
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-16
  • 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 with the carestation 620 650 and 650c. an unexpected transition to a system malfunction state can occur on the carestation 600 series systems. when this does occur you will see this message displayed on the screen: "system malfunction internal problem prevents normal operation. use backup ventilation. to restart turn power off and on." if the system malfunction is left unresolved it could result in loss of mechanical patient ventilation which could lead to hypoxia.

Device

CARESTATION 650
  • Model / Serial
    Model Catalog: 1012-9650-000 (Lot serial: SM716430070MA); Model Catalog: 1012-9650-000 (Lot serial: SM717020049MA); Model Catalog: 1012-9650-000 (Lot serial: SM716200045MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100033MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080059MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080058MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080057MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080056MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100036MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100027MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430026MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310029MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430025MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100155MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100018MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310012MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100026MA); Model Catalog: 1012-9620-000 (Lot ser
  • Product Description
    CARESTATION 650;CARESTATION 620
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)