| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00861-1 |
| Product Name/Description |
Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used for medical imaging acquisition)
ARTG Number: 191068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This action has been initiated due to potential incorrect display of mammographic measurements. The problem is that there is variability of how the Estimated Radiographic Magnification Factor (ERMF) is provided in the DICOM header data. When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image) the measurements are not the same.
Use of this product may lead to additional imagining, such as MRI and/or biopsy follow-up, before referring a patient to any surgical procedures. Particularly if an MRI or ultrasound is done the incorrect measurements would be identified as erroneous. This may result in a delay in diagnosis or treatment or patient misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software upgrade will be implemented as a permanent correction. In the interim, users are advised not to use Merge PACS mammographic measurements until upgraded. The ability to create any measurements and annotations are controlled by together by a set of privileges which should be disabled until upgraded. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |