| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00071-1 |
| Product Name/Description |
Mammomat Inspiration System with software version VB30 and Biopsy functionality
Catalogue Number: 10140000 (with software version VB30 and with a Biopsy option)
ARTG Number: 274541 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has become aware of potential errors that may occur while performing a biopsy. The system may freeze and biopsy functionality may become unavailable in the following situations:
- drop of the compression force, e.g. this may occur due to a patient's sudden movement during the active targeting phase
- use of the inversion tool while the scout image is active during the targeting phase.
As a result of system freeze, the biopsy may have to be repeated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will release a software update to resolve the issue. Siemens service engineer will contact affected customers to schedule the software update. In the interim, Siemens is advising users to follow these instructions:
1) Do not close the error message window when it is displayed. Instead, cancel the active target before closing the window. Users can start all over after the completion of these steps.
2) Users are advised not to use the inversion tool while the scout image is active.
In the event of a system freeze, the acquisition workplace must be rebooted.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |