Events

Recall of BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(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-00327-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00327-1
  • 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
    The detector braking systems may be rendered ineffective resulting in one or both detectors moving to their mechanical limit. in the case of this kind of failure, the detector motion cannot be halted using normal operator intervention (e-stop, collimator contact sensor activation). the detector(s) may move down onto the patient or operator, potentially resulting in entrapment and/or serious injury or death. any brightview, brightview x or brightview xct where components on the braking system have been serviced is potentially affected. systems that were serviced and received a complete brake assembly are not affected by this issue.
  • Action
    Customers are advised to immediately discontinue use of the system until Philips Service has undertaken the inspection of the system. The system can be returned for clinical use if the system brakes pass inspection. If the system brakes fail inspection, the system will be returned for clinical use once the correction is implemented.

Device

BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nucl...
  • Model / Serial
    BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT systems)Affected component(s) or subsystem(s):Radius DrivePart Numbers: 453560304611, 453560312361, 453560303641Tangent DrivePart Numbers: 453560304611, 453560312361, 453560303761Roll DrivePart Numbers: 453560313601, 453560303781, 453560313881ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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