Events

Recall of iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128

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-2016-RN-01444-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01444-1
  • 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
    An incorrect current rating label has been applied to the rear side of the imr (single computer) host cabinet (4598-004-44981).The non-conforming label states the current rating as 4.8a (instead of 2.4a), as defined in the host rack imr specifications. the correct label on the host imr rack should have electrical rating values of: 230v — 2.4a, 50/60 hz.
  • Action
    Philips Healthcare is notifying the affected users of those issues via this letter. A Philips Field Service Engineer will contact those users to schedule the Rack/Cabinet label re-work on-site. Reference Field Change Order (FCO) 72800667. This action has been closed-out on 23/06/2017.

Device

iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128
  • Model / Serial
    iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128Part Number: 459800444981ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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