Events

Recall of Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT 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-2017-RN-00260-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00260-1
  • 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
    Several issues have been identified with philips brightview, brightview x and brightview xct leading to a need to re-scan the patient:-brightview xct systems only:- motion controller emits the warning message; and- door interlock switch with x ray perform.For both brightview x and xct systems:- detector contacts head holder when performing patient unloadfor brightview, brightview x, and brightview xct systems:- jetstream freezes during gated planar scan.
  • Action
    Philips is notifying the affected users of these issues via this Customer Information Letter. Customers will be contacted by a Philips Field Service Engineer for implementation of the necessary software corrections free of charge.

Device

Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medic...
  • Model / Serial
    Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT systems)Model Number and Device Name: 882480 - BrightViewSoftware versions: 1.2.1, 1.2.2, 1.2.3, 1.2.4 and 1.2.5Model Number and Device Name: 882478 - BrightView X882482 - BrightView XCT882454 - BrightView X upgrade to XCTSoftware versions: 2.5.1, 2.5.2, 2.5.3, 2.5.4 and 2.5.5ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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