Events

Recall of IntelliSpace PACS 4.4 (Picture archiving and communication system)

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-2013-RN-01072-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01072-1
  • 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
    Philips healthcare has become aware of a potential problem with the philips intellispace pacs system. there is a software issue which in certain circumstances could result in the unintended deletion of images sent to the intellispace pacs 4.4 before they are available for access by system users. timing of images being received by the pacs varies based on study size or modality configuration. if additional images are received into the study input folder as the input folder is being deleted, those images are not saved and can result in missing images.
  • Action
    Philips is providing temporary workaround instructions to mitigate the failure mode occurring. Philips is developing a software update that corrects this issue. It is anticipated this update will be available before the end of October 2013.

Device

IntelliSpace PACS 4.4 (Picture archiving and communication system)

Manufacturer

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