Events

Recall of AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras)

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-00384-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00384-1
  • 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 autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90° or 180° relative to one another. however, certain gamma cameras, e.G., the marconi axis and irix cameras, permit acquisitions at other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro, and the results will likely be erroneous.Incorrect computational results may lead, under certain circumstances to misdiagnosis, e.G., an incorrect assessment of a patient’s myocardial perfusion, in which case, the patient may not receive further indicated diagnostic tests or therapy, putting the patient at risk of a subsequent cardiovascular event.Philips has not received any report of any patient harm associated with this issue.
  • Action
    Philips is advising users to follow instructions in the customer letter to determine whether the system is affected. If it is affected, users are asked NOT to use the AutoSPECT Pro application on the affected data sets until Philips modifies its software to prevent it from reconstructing data acquired using these modes. Instead, use the reconstruction applications on the camera’s native processing computers (e.g. Odyssey). Philips is recommending a review of previously processed data based on the clinical context. This action has been closed-out on 27/01/2017.

Device

AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0...
  • Model / Serial
    AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras)ARTG Number: 117441
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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