Events

Recall of Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Radiation Oncology Systems.

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
    20038
  • Event Initiated Date
    2016-04-18
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    Autospect pro is a spect reconstruction application residing on the extended brilliance workspace nm workstation. it was found that the software may display incorrect results if the data processed is derived from spect acquisitions using detectors positioned at angles other than 90° or 180° relative to on another. reliance on these results could lead to 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 for a subsequent cardiovascular event. many gamma cameras only allow acquisitions at relative 90° or 180°, so this issue cannot occur when reconstructing data obtained with those systems. philips has not received any report of any patient harm associated with this issue.
  • Action
    Software to be upgraded

Device

Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Manufacturer

Philips Radiation Oncology Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA