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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00864-1
Product Name/Description 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
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/06/2016
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 02 9006 1662 – Emergo Australia