Events

Recall of Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2016-RN-00862-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00862-1
  • 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
    This recall has been initiated due to an issue in which the patient name in the halo title bar may not update to match the name on displayed images due to the java running out of memory. this may result in a mismatch of the displayed patient name on the halo title bar and the displayed images. this may result in a delay in diagnosis or treatment or patient misdiagnosis. there have been no reports of injuries as a result of this issue.
  • Action
    A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communication...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia