| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00768-1 |
| Product Name/Description |
FujiFilm Digital Mammography System AMULET (FDR MS-1000)
Serial Number: 07120035
ARTG Number: 159785 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
In rare cases the Amulet Mammography system may freeze during Stereo/Biopsy-Movement in biopsy examination. Once this failure occurs, continued system operation is impossible until a FujiFilm technician corrects the issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
FujiFilm is requesting users to discontinue use of the biopsy unit until the faulty components are replaced. Screening without use of the biopsy unit may still be performed in the interim. |
| Contact Information |
02 9466 2600 - Fujifilm National Service and Support |