Events

Recall of Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit

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-00210-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00210-1
  • 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
    It has been identified that the intended use statement listed in the instructions for use (ifu) is stated incorrectly. a revision of the ifu with amendments (specifically regarding the functional capabilities of the system) will be released. the amended intended use in the ifu is as follows:brightview xct is a gamma camera for single photon emission computed tomography (spect) and integrates with an attenuation device consisting of flat panel x-ray imaging components. brightview xct produces non-attenuation corrected spect images and attenuation corrected spect images with x-ray transmission data that may also be used for scatter correction. the nuclear medical images and brightview xct images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localisation of the nuclear medicine data. the brightview xct imaging system should be used only by trained healthcare professionals.
  • Action
    Philips is advising users to be aware of the updated "Intended Use Statement" highlighted in the Customer Information Letter Users are further advised to continue using the system according to their training.

Device

Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit
  • Model / Serial
    Philips BrightView XCT and Philips BrightView X to XCT Upgrade KitModel Numbers: 882482 and 882454All software versionsARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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