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
    27253
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-28
  • 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
    In some instances the user interface on the system may appear as though it has ceased responding to commands. in this case while the interface may not reflect any of the changes being commanded to the user it is in actuality updating the system computer with the commands requested. this may result in a situation where the user interface indicates a different technique selection than is actually selected on the system. therefore the potential exists for the system to perform a different technique selection for an exposure than may be indicated to the user.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 5555000-3 (Lot serial: N/A); Model Catalog: 5555000-4 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: N/A); Model Catalog: 5555000-6 (Lot serial: N/A)
  • Product Description
    OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)