Events

Recall of Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2018-RN-00347-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00347-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded. philips has become aware of one instance where this happened in a philips system. investigation found the metal burst disk assembly in the vent path did not perform according to specifications.
  • Action
    As an interim measure Philips is referring users to follow the relevant sections of the current IFU in the event helium gas escapes into the examination room during a magnet quench; and As a long term correction Philips will schedule an inspection of all MRI systems that may be affected by this issue and where applicable the spare 3” metal burst disk will be replaced during this inspection. Philips advises that planning will be carefully coordinated and where possible this correction will be done during off hours to reduce any disturbance to customers.

Device

Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T
  • Model / Serial
    Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5TARTG Number: 230064(Philips Electronics Australia - MRI system, full-body, superconducting magnet)
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA