Events

Recall of Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual Oil Accumulator within the Gantry (combination diagnostic imaging system (PET/CT)

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-00983-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00983-1
  • 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
    A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
  • Action
    No action needs to be taken at this point by the customer or user. Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems.

Device

Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual Oil Accumulator within the Gantry (combination...
  • Model / Serial
    Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual Oil Accumulator within the Gantry (combination diagnostic imaging system (PET/CT)Multiple serial numbers affectedARTG Numbers: 98868 and 118077
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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