Events

Recall of Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)

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-2013-RN-00038-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00038-1
  • 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
    Philips healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. philips has determined the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake’s screws.
  • Action
    If the couch moves down unexpectedly, please discontinue use of the device and contact your local Philips Field Service Engineer. A Philips Field Service Engineer will perform a brake repair or replacement on the affected systems to resolve the issue.

Device

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iC...
  • Model / Serial
    Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)Multiple serial numbers affectedARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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