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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01045-1
Product Name/Description IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication system for radiology)

ARTG Number: 149923
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/08/2016
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue The Image Fusion functionality may display an incorrect calculation of Standard Uptake Value (SUV) when loading the presentation state of image for a previously calculated (and saved) Region of Interest (ROI). This software defect could lead radiologists to base their diagnosis/report on erroneous anatomical measurement leading to incorrect medical treatment.

To date, there have been no reports of patient incidents.
Recall Action Recall for Product Correction
Recall Action Instructions Emergo is advising users to confirm the software version installed on their IntelePACS system and if the version is 4-10-1 or earlier, to authorise Intelerad to install an upgrade to InteleViewer 4-11-1 or later. Users are advised to stop using the presentation states functionality of the Image Fusion module until they have InteleViewer 4-11-1 or later installed on their workstation. This action has been closed-out on 02/03/2017.
Contact Information 02 9006 1662 - Emergo Australia