Events

Recall of Philips IntelliSpace PACS 4.4

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Healthcare Informatics Inc.

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
    17290
  • Event Initiated Date
    2014-09-03
  • 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
    A problem has been detected in the philips intellispace pacs 4.4 software that, if it were to occur, could pose a risk for patients. although the data is correct in intellispace pacs, any changes to data may not be updated before auto export. if diagnosis is performed utilizing exported data on a 3rd party device the user may not be aware of any unchanged patient. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Action
    Software to be upgraded

Device

Philips IntelliSpace PACS 4.4

Manufacturer

Philips Healthcare Informatics Inc
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA