Events

Recall of BRIVO XR385 DIGITAL DIAGNOSTIC RADIOGRAPHY 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
    111369
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-18
  • 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 following issue is being addressed by ge healthcare file no. fmi 17114: ge healthcare has become aware of an issue with the vrad detectors when used during imaging in tabletop mode within a short period of time after weight is directly applied to the detector. the placing of weight on the detector can introduce image artifacts which can result in patient exam retakes.

Device

BRIVO XR385 DIGITAL DIAGNOSTIC RADIOGRAPHY SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: BRIVO XR385 (Lot serial: 000A1E4CN077P1); Model Catalog: BRIVO XR385 (Lot serial: 000A1E4CN077R2); Model Catalog: BRIVO XR385 (Lot serial: 000A1E5AN059K1)
  • Product Description
    BRIVO XR385
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)