| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00863-1 |
| Product Name/Description |
Merge PACS with software versions 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2 (picture archiving and communication system)
Distributed between June 2008 and June 2015
ARTG Number: 191068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated due to Merge PACS inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from Office PACS. These presentation states are known as foreign presentation states. PACS 6.5.5 introduced the feature to be able to display foreign presentation states. However this feature was only available on the primary study in any given viewer instance. It did not apply to prior comparison studies that were opened in the same viewer. Users might assume that if the annotations are available in the primary study, they would also be shown if available on the prior comparison studies.
Use of this product may cause a user to believe that there was nothing significant seen in the prior image which may result in improper treatment.
There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo are advising users to open prior comparison studies in the secondary viewer to check if there were annotations and read the report, or visit notes pertaining to that study to see if there are any noted findings that are otherwise not apparent. Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 23/05/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |