Events

Recall of Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2 storage enabled (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-00864-1
  • 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-00864-1
  • 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 icea which could result in unrecoverable loss of data when using tiered storage on icea. the issue can arise if a study has purged from tier 1 (i.E. via high water mark) and only resides in tier 2 and then the study is requested to be updated.In a tiered storage environment older data (less frequently accessed data) is staged to a second storage tier for long term storage. this staging process frees up space on the first storage tier for newer data. in rare circumstances, where the data that exists only on the second tier needs to be accessed, a software issue could lead to data being purged from both the first and second tier resulting in data loss. this issue may result in an archived study not being available for future viewing (i.E. as a prior study for comparison purposes, etc.). if prior studies are not available for viewing, this may lead to delay in treatment in determining the progression of the disease.
  • Action
    Emergo is advising users to create a new object and remove the reference to the original version in order to prevent the issue from occurring. Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2...
  • Model / Serial
    Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2 storage enabled (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