| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01234-1 |
| Product Name/Description |
IntelePACS InteleViewer with software version 3-5-1 to 4-15-1
ARTG Number: 149923 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Following a complaint from a client, Intelerad is notifying users of a problem that could occur on their IntelePACS software. The magnification tool functionality may display incorrect images if the user is utilising reverse ordering. In this instance, the image shown in the tool will not be the one in the current viewport. The tool may be displaying a magnified image for a different slice of the series. This software defect could lead radiologists to delay their diagnosis/report. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users to be aware of this issue. A software correction will be implemented to rectify the issue.
This action has been closed out on the 03/12/2018. |
| Contact Information |
02 9006 1662 - Emergo Customer Service Centre |