Events

Recall of GYROSCAN MAGNETIC RESONANCE IMAGING SYSTEM - ACS - NT

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
    37057
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-18
  • 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 instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the quadrature body coil (qbc).

Device

GYROSCAN MAGNETIC RESONANCE IMAGING SYSTEM - ACS - NT
  • Model / Serial
    Model Catalog: 452213219858 (Lot serial: 5438); Model Catalog: 452213219857 (Lot serial: 5438); Model Catalog: 452213219856 (Lot serial: 5438); Model Catalog: 452213219855 (Lot serial: 5438); Model Catalog: 452213219854 (Lot serial: 5438); Model Catalog: 452213219853 (Lot serial: 5438); Model Catalog: 452213219852 (Lot serial: 5438); Model Catalog: 452213219851 (Lot serial: 5438); Model Catalog: 452213276191 (Lot serial: 5465); Model Catalog: 452213219858 (Lot serial: 5465); Model Catalog: 452213219857 (Lot serial: 5465); Model Catalog: 452213219856 (Lot serial: 5465); Model Catalog: 452213219855 (Lot serial: 5465); Model Catalog: 452213219854 (Lot serial: 5465); Model Catalog: 452213219853 (Lot serial: 5465); Model Catalog: 452213219852 (Lot serial: 5465); Model Catalog: 452213219851 (Lot serial: 5465); Model Catalog: 452213276191 (Lot serial: 5418); Model Catalog: 452213219858 (Lot serial: 5418); Model Catalog: 452213219857 (Lot serial: 5418); Model Catalog: 452213219856 (Lot serial: 5418); Model Catalog:
  • Product Description
    GYROSCAN MAGNETIC RESONANCE IMAGING SYSTEM - ACS - NT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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