Events

Recall of INGENIA 3.0T CX

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
    16504
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-17
  • 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 thickness and location of the shielding material must be installed according to the shielding requirements provided by philips. in cases where the requirements are not followed the distance between the passive shielding rear wall and the magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. these stronger forces may lead to shearing of the magnet vibration pads. in a worst case scenario it may result in displacement of the magnet. displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.

Device

INGENIA 3.0T CX
  • Model / Serial
    Model Catalog: 781271 (Lot serial: 78012); Model Catalog: ACHIEVA XR (Lot serial: 35062); Model Catalog: ACHIEVA 3.0T (Lot serial: 38195); Model Catalog: ACHIEVA 3.0T (Lot serial: 38109); Model Catalog: 3.0T (Lot serial: 71068); Model Catalog: 3.0T (Lot serial: 71300); Model Catalog: 3.0T (Lot serial: 71481); Model Catalog: 3.0T (Lot serial: 71081)
  • Product Description
    INGENIA 3.0T CX;ACHIEVA XR SYSTEM - MAIN UNIT;ACHIEVA 3.0T MRI SYSTEM - MAIN UNIT;INGENIA 3.0T
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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