Events

Recall of IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)

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-00364-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00364-1
  • 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
    During spect reconstructions using attenuation correction and scatter correction, no scatter correction is being applied in the autospect pro application on intellispace portal with the software versions mentioned above. in addition, resolution recovery is not applied correctly in spect reconstructions using astonish in autospect pro on intellispace portal unless the data is acquired with vxgp collimators. the occurrence of either problem may result in image quality degradation that could result in misdiagnosis under certain conditions.
  • Action
    Philips is providing work around instructions to ensure the continued safe use of the AutoSPECT Pro until a software update can be provided to correct the issue. This action has been closed-out on 12/02/2016.

Device

IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagn...
  • Model / Serial
    IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)Affected IntelliSpace Portal software versions: v5.0.0, v5.0.1, v5.0.2 and v6.0.0ARTG Number: 188684
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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