Events

Recall of IntelliSpace PACS 4.4 (Radiology 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-2014-RN-00952-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00952-1
  • 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
    In philips intellispace pacs 4.4, there is feature which allows the optional configuration of auto export of resolved study exception immediately after resolution. when this configuration is used, it is possible for a system timing issue to occur when exporting data to 3rd party devices. if this system timing issue occurs when demographics are updated, such as during exception resolution and the study is immediately exported, the patient demographic information can be incorrect in the exported data. although the data is correct in intellispace pacs if diagnosis is performed on this exported data using a 3rd party device the user may not be aware of unchanged patient data is being utilised. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient. the hazard involved is that diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Action
    Each site will be contacted by Philip’s Technical Account Manager and notified if Auto Export is configured at the site and to schedule either the disabling or the correction of the Auto Export Feature. Determined by site utilization of the feature, Philips will schedule and deploy software correction or will disable the Auto Export Feature for all IntelliSpace 4.4 installations impacted by this issue. This action has been closed-out on 17/08/2016.

Device

IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)
  • Model / Serial
    IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)All versions of IntelliSpace PACS 4.4 with Auto Export Feature Enabled are affectedARTG Number: 178437
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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