Events

Recall of BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging 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-2016-RN-00787-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00787-1
  • 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 non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan. a certain set of conditions identified in the customer letter are required to create the situation. there have been no reports of any injuries associated with this issue. however, users are reminded to ensure patients are observed closely at all times, and the e-stop is activated to prevent contact with the patient, if required.
  • Action
    Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.

Device

BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear...
  • Model / Serial
    BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)Model numbers: 882478, 882482ARTG numbers: 117642, 17440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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