Events

Recall of INTERA 1.5T MRI SYSTEM - SENSE XL TORSO COIL

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
    82946
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-31
  • 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 risk of burn to the patient when the cables of the sense xl torso coil (achieva 1.5t and intera 1.5t mri systems) are placed too closely to the patient's anatomy.

Device

INTERA 1.5T MRI SYSTEM - SENSE XL TORSO COIL
  • Model / Serial
    Model Catalog: MMT 3091 (Lot serial: )
  • Product Description
    ***SAME AS ABOVE***
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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