Events

Recall of BrightView XCT 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-2014-RN-01226-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01226-1
  • 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 has identified two issues with the brightview xct spect/ct systems: 1) whilst performing a clinical spect/ ct study on a brightview xct spect/ct systems, the ct portion of the scan may be interrupted and not complete successfully. this problem is not detectable by the user prior to the interruption of the ct acquisition. interruption of the ct acquisition portion of the scan may necessitate a re-scan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. the additional radiation would be less than the amount delivered from a single successful scan of that body segment.2) investigation of generator faults from the field have identified that the ground connection on the x-ray generator cabinet may have been wired incorrectly during installation.
  • Action
    Philips is advising users of the issue and providing work around instructions should the problem occur. Philips is also updating the XCT generator configuration to increase tube life and implementing a software update.

Device

BrightView XCT SPECT/CT systems

Manufacturer

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