Events

Recall of Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (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-00860-1
  • 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-00860-1
  • 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 because of an error when viewing prior results. a pixel offset issue can occur when prefetching a prior image from the lta to a local cache resulting in the viewer being unable to display it. the original study on the lta is unaffected. in icea version 8.80, the pixel offset algorithm for images changed from absolute to relative offset. in normal operation, the new offset algorithm presents no risk. however, a pixel offset issue can occur when running a heterogeneous mix of icea versions spanning the lta and fic. more specifically, the issue can occur when running a pre-8.80 version of the lta with an 8.80 or later version for the fic. if prior studies are not available for viewing, this may lead to delay in treatment for the patient, however there are no reports of injuries as a result of this issue.
  • Action
    Merge has a released software fix available for this issue. In the interim, Emergo is advising users of the following workaround. Do not run a mix of pre-8.80 software for LTA and an 8.80 version or later for the FIC. When prefetching, send uncompressed studies from the LTA to the FIC. Restore images manually from LTA using the webadmin tool. This action has been closed-out on 22/02/2017.

Device

Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (a picture arc...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia