Events

Recall of BRIGHTVIEW XCT IMAGING SYSTEM - UPGRADE KIT BRIGHTVIEW X TO BRIGHTVIEW XCT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    62540
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-03
  • 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 inteded use statement listed in the instructions for use (ifu) for brightview xct systems is stated incorrectly.

Device

BRIGHTVIEW XCT IMAGING SYSTEM - UPGRADE KIT BRIGHTVIEW X TO BRIGHTVIEW XCT
  • Model / Serial
    Model Catalog: 453560825881 (Lot serial: > 10 Lots contact MFG)
  • Product Description
    BRIGHTVIEW XCT IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC