Events

Recall of Philips Ingenuity CT 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-2017-RN-00261-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00261-1
  • 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
    It has been identified that the couch rear subframe cover may not be strong enough in the area around the philips logo lettering to prevent cracking during normal operations. if the cover is impacted by excessive force as a result of contact with medical transportation equipment or accessories, the cover may crack, creating a potential for injury.
  • Action
    Philips is advising users to observe the cautions included in their system user documentation and retain the recall notification with the Instructions For Use (IFU). Users are further advised to contact Philips if there are indications that their system is not operating properly. This action has been closed-out on 01/03/2018.

Device

Philips Ingenuity CT system

Manufacturer

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