Events

Recall of Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic 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-2012-RN-00890-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00890-1
  • 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
    The patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. this can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the unload foot switch. this can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released.
  • Action
    Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch.

Device

Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (...
  • Model / Serial
    Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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