Events

Recall of BRILLIANCE ICT SYSTEM - 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
    82812
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-01
  • 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
    There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner's main bearing may come loose. if this occurs the part(s) will not be expelled however a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue. raison du rappel il est possible que des vis retenant une partie interne du statif (anneau de reaction) au mecanisme de soutien de l'appareil d'irm se devissent. si cela se produit la ou les pieces ne seront pas expulsees.Cependant un bruit peut etre entendu en provenance du statif. il n'y a aucun risque de lesion au patient ou a l'operateur decoulant de ce probleme.

Device

BRILLIANCE ICT SYSTEM - SYSTEM
  • Model / Serial
    Model Catalog: 728306 (Lot serial: N/A); Model Catalog: 728311 (Lot serial: N/A)
  • Product Description
    BRILLIANCE ICT SYSTEM-SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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