| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01040-1 |
| Product Name/Description |
Stereo Biopsy Device used with Mammomat Inspiration Mammography System
Material number: 10140000 (Mammomat Inspiration)
Serial numbers: 1541, 2082
ARTG number: 144223 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already inserted, it could lead to an unintentional patient injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that in case the needle holder moves unintentionally to press the emergency stop. Siemens is recommending inspection of the safety switch before every biopsy until the problem is solved. Siemens is preparing a modification of the safety switch that will resolve this potential malfunction. The field modification will be available beginning of October. This action has been closed-out on 07/06/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |