Events

Recall of Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3(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-00873-1
  • 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-00873-1
  • 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 the impacted versions of icea allow images to be stored to the icea without pixel data. - image was retrieved by radsuite from icea, a qc action was performed, & sent back to icea. - image was sent to icea with pixel data but the pixel data was not stored with the image to icea. the investigation found that there is a networking scenario where the network dropped the connection after sending the header information but before the pixel data arrived. icea stored the image without the pixel data.- image was sent to icea without pixel data & the image was stored to icea. the pixel data may have been lost by the device that sent the data to icea.A side effect of images without pixel data is performance degradation caused by the system continuously attempting to route the images to the peer system that fail to store. there could be delay in treatment in determining the progression of disease.
  • Action
    Emergo is advising users that there is no work around for the issue, however the error is obvious to users using PACS viewer, as it is indicated that there is a missing image (slice) from the study. Users not using PACS viewer may not be notified of the error. Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and inc...
  • Model / Serial
    Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3(a picture archiving and communications system)ARTG Number: 206683
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia