Events

Recall of OPTIMA XR200AMX X-RAY SYSTEM - 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
    27245
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-23
  • 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 an issue related to the operation of the safety latch within the column that supports the horizontal arm. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. a fall of the arm assembly could result in bodily harm to a person. there have been no incidents or injuries reported as a result of this internally found issue.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)