| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00870-1 |
| Product Name/Description |
Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2
(a picture archiving and communication system)
ARTG Number: 191068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Unviewed images may not display after the last Hanging Protocol (HP) step when the user preference setting "Show unviewed images after the last hanging Protocol (MG only)" is selected. This can occur if the last HP step was skipped. This is most commonly encountered if there are additional views created for the study.
This may impact diagnosis when images are unavailable for viewing, however there have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users to not have the red-x icon available in the reading physician's toolbars to close the study. This will trigger a warning message that there are unviewed images available.
Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 27/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |