| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00872-1 |
| Product Name/Description |
Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication system)
ARTG Number: 191068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
This action has been initiated because the cross reference lines a.k.a. cut lines or localiser lines may not display properly. This is due to math error when calculating the cut line position for studies with extremely high precision in the DICOM tag Image Orientation Patient (0020,0037) containing values of greater than 15 significant digits. The patient tag on affected images includes the value "e-16". When the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study. This may impact diagnosis when images are unavailable for viewing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Merge is working on correcting the issues and will inform customers once a fix is available. In the interim, users are advised that in order to view the study with the cross reference lines, it is recommended to view the study on another workstation of the modality device. Also, examine the image orientation patient tag to see if there are values with "e-16" included to see if a study in question could be affected. This action has been closed-out on 27/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |