Events

Recall of IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinical images from different imaging modalities i.e., CT, NM, MR and enables advanced visualisation)

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-00977-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00977-1
  • 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
    The following issues could lead to misdiagnosis which may result in patient mistreatment:1. when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed may be different from the ef originally displayed when the bookmark was first created. 2. when processing using autoquant, emory cardiac toolbox, corridor4dm, or neuroq nm clinical applications, the patient study presented to the reviewing physician may be for a different patient than the one selected from the patient directory. 3. while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is maximised or if the image is zoomed in or out. 4. while displaying pet images within ct viewer, the suv results displayed are different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumour tracking applications.
  • Action
    Philips Healthcare is providing users with temporary workarounds in the customer letter for the identified problems. The issues have been corrected in software versions 5.0.2.3 and 6.0.2.3. Philips Service Engineer will contact the customers for implementation of the software update on the affected systems. This action has been closed-out on 9/08/2016.

Device

IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinica...
  • Model / Serial
    IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinical images from different imaging modalities i.e., CT, NM, MR and enables advanced visualisation)Models:IntelliSpace Portal DX/HX/EX IntelliSpace Portal IXIntelliSpace Portal LX SPECTARTG Number: 188684
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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