Events

Recall of CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)

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-2015-RN-00079-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00079-1
  • 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
    Philips is informing the customer that the lithium polymer batteries, used in the cdas upgraded intera mr systems equipped with the basic triggering unit may fail after being physically dropped from a height (i.E. from waist height to floor). the failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. the failure of the battery may occur instantly or may be delayed for a short period of time.
  • Action
    Philips is providing guidelines to reduce the risk of the battery failure as well as instructions to mitigate the risk of harm in case the battery was dropped. Philips is replacing the affected batteries free of charge. This action has been closed-out on 03/08/2016.

Device

CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic R...
  • Model / Serial
    CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)Part numbers: 9065 and 9067Units Affected: All batteries with date codes 2808 or earlierARTG Number: 98887
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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