| 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 |
|
| 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 |