Events

Recall of BRIVO XR285AMX X-RAY SYSTEM

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
    24607
  • Event Risk Class
    III
  • Event Initiated Date
    2012-03-16
  • 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
    The reason for the recall is because when the collimator is rotated beyond 10 degrees from the 0 degree setting relative to the x-ray tube the total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or the width exceeds 2 percent of the distance from the source to the center of the visually defined field. this is not compliant with iec 60601-1. when the collimator is rotated relative to the x-ray tube the corners of the x-ray field are under exposed or cut off ~3.5% relative to the light field displayed. anatomy located at the extreme corner(s) of the displayed light field may not be captured on the radiographic image resulting in a potential image retake.

Device

BRIVO XR285AMX X-RAY SYSTEM
  • Model / Serial
    Model Catalog: 5555000 (Lot serial: N/A); Model Catalog: 5555000-2 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a)
  • Product Description
    BRIVO XR285AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)