Events

Recall of Philips IntelliSpace Portal Diagnostic Imaging System

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

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
    17324
  • Event Initiated Date
    2014-09-09
  • 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
    The manufacturer has identified several software issues with this system which could lead to misdiagnosis., 1. when reopening a bookmark generated from processing a muga scan the ejection fraction displayed may be different to the originally displayed value, 2. a patient study may be presented to the revieweing physician with the incorrect patient data, 3. while using the nm view application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximised or if the image is zoomed in or out, 4. while displaying pet images within ct viewer, the suv results displayed may be calculated with an suv method different from the one specified in system preferences.
  • Action
    Software to be upgraded

Device

Philips IntelliSpace Portal Diagnostic Imaging System

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA