Events

Recall of BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16

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-2018-RN-00049-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00049-1
  • 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 an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.
  • Action
    Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange. Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system. It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera. It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU. Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.

Device

BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
  • Model / Serial
    BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16Product Number - 8823500 Precedence 16Product Number - 882351 Precedence 6 SliceProduct Number - 882478 BrightView X Product Number - 882480 BrightView SPECTProduct Number - 882482 BrightView XCTARTG Number: 117440 (Philips Electronics Australia Ltd - SPECT/CT diagnostic imaging system)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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