Events

Recall of BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)

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-00682-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00682-1
  • 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
    During a daily xct quality assurance phantom scan for image quality and hounsfield unit (hu) linearity an operator experienced resistance when engaging the locking handle of the fpd in the deployed position. with the locking handle in the locked position, the flat panel detector (fpd) locking mechanism was not locked, moved unexpectedly and contacted the imaging detector during system movement. philips’ investigation determined that the internal linkage shaft broke preventing the fpd from being locked into its correct deployed position.
  • Action
    Philips Healthcare Field Service Engineers will undertake a field corrective action to ensure no unexpected movement of the Flat Panel Detector. Philips is advising their customers to cease use of the XCT Flat Panel Detector until the implementation of the field corrective action. This action has been closed-out on 18/02/2016.

Device

BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)
  • Model / Serial
    BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)ARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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