Events

Recall of Ingenia MR FlexTrak Trolley

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-2014-RN-00623-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00623-1
  • 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
    When using the ingenia mr flextrak trolley there is a risk of clamping the operator’s foot between the floor and the hydraulic unit of the trolley.
  • Action
    Philips is replacing the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with a protection bumper that prevents foot clamping. Thia action has been closed-out on 10/02/2016.

Device

Ingenia MR FlexTrak Trolley
  • Model / Serial
    Ingenia MR FlexTrak TrolleyProduct Codes: 989603019291, 989603019292 and 989603019293ARTG Number: 98887
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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