Events

Recall of BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)

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-00051-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00051-1
  • 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 have identified 4 issues with the brightview systems:1. during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan. although unlikely, if the collision sensors malfunction & the operator fails to activate the e-stop, this could lead to serious bodily injury for the patient.2. during a scan, the gantry motion may halt prematurely. this causes the scan sequence to pause.3. operator will receive a warning message that the scan may not complete & re-mark the points used to define the orbit when defined with a detector relative angle of 90 & head first supine/feet first prone setting. 4. resolved defects section of user release document 1.2.4/2.5.4 for brightview, brightview x & xct listed 2 pre-programmed motions (ppms) whose motion sequences were changed by the release of s/w v1.2.4/ 2.5.4.
  • Action
    The sponsor will provide a system software upgrade to correct the reported issues.

Device

BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (ver...
  • Model / Serial
    BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)ARTG Numbers: 117642 and 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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