| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00079-1 |
| Product Name/Description |
ACUSON S2000 Automated Breast Volume Scanner (ABVS)
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
On some ACUSON S2000 ABVS systems, the edges on the inside of the transducer pod may not have been completely deburred to avoid sharp edges. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Siemens Service Engineer will perform an onsite inspection to determine if burrs are present on your device. The service engineer will remove any burrs if present. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |