Events

Recall of BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM

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
    72851
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-07
  • 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
    Philips has become aware that while performing a clinical spect/cy study on a brightview xct spect/ct system the ct portion of the scan may be interrupted (stopping the ct exposure at the time of interruption) and may not complete sucessfully. an incomplete study may result in the operator having to retry the interrupted segment acquisition to complete the patient exam.

Device

BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM
  • Model / Serial
    Model Catalog: 453560749161 (Lot serial: > 10 numbers contact mfg); Model Catalog: 453560462131 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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