Events

Recall of MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (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-00462-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00462-1
  • 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 identified a software defect that results in incorrect display of absolute values when measuring pixel density and statistics for region of interest. this issue occurs when enhanced mr and enhanced ct images are sent to the pacs with modality lut (look up tables) as defined in dicom functional group. there could be misdiagnosis if a clinician relies on the incorrect density measurements displayed. this issue does not affect images that are not enhanced image objects.
  • Action
    Philips is advising their customer that they must configure the MRI and CT devices to send regular CT and MR DICOM image objects (not enhanced) to PACS. Philips is developing a software update to address the issue. This action has been closed-out on 18/02/2016.

Device

MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)

Manufacturer

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