Events

Recall of BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)

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-00035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00035-1
  • 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
    Several software issues were identified which will be corrected with the release of a new software version. 1. when positioning for a relative 180 degree non-circular acquisition, if the second (bottom) detector is not positioned correctly, it may result in an inappropriate rotation orbit calculation for the patient being imaged. this may result in the detectors coming in contact with the patient.2. as the gantry system moves to a relative 90 degree scan position of the detectors, a patient/operator may move their hands or arms into the path of the detectors, resulting in contact with the patient/operator. 3. when a user manually positions the patient for an exam and is translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet which may result in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.
  • Action
    Philips Healthcare is advising users to always follow the Instruction For Use (IFU), and is providing additional instructions to prevent the issues from occurring. A software upgrade will be installed on all affected systems as a permanent correction for the issues.

Device

BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)
  • Model / Serial
    BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)BrightView SPECTProduct Code: 882480BrightView XProduct Code: 882478BrightView XCTProduct Code: 882482ARTG Numbers: 117642 and 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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