Events

Recall of Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication 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-00870-1
  • 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-00870-1
  • 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
    Unviewed images may not display after the last hanging protocol (hp) step when the user preference setting "show unviewed images after the last hanging protocol (mg only)" is selected. this can occur if the last hp step was skipped. this is most commonly encountered if there are additional views created for the study.This may impact diagnosis when images are unavailable for viewing, however there have been no reports of injuries as a result of this issue.
  • Action
    Emergo is advising users to not have the red-x icon available in the reading physician's toolbars to close the study. This will trigger a warning message that there are unviewed images available. Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 27/02/2017.

Device

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS vers...
  • Model / Serial
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia