| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00893-1 |
| Product Name/Description |
Mammomat Inspiration (diagnostic mammography X-Ray system)
ARTG Number: 144223
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
An addendum of the operating manual has been released to provide more detailed description about the emergency release of the compression unit in case of system error or a power failure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is providing an update to the Instructions for Use (IFU). |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |