| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00108-1 |
| Product Name/Description |
Amulet (FDR MS-1000), Amulet f (FDR MS-2500) & Amulet Innovality (FDR MS-3500) with Biopsy Unit
Serial Numbers: 26340096, 37220054 & 36920025
ARTG Number: 159785 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
During a biopsy study using the FUJIFILM Digital Mammography System, it has been found that the User Manual lacks a description for handling some errors. If users do not address the recovery procedure properly, there may be a possibility that the examination is suspended leading to patient re-examination. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
FujiFilm has developed a simplified manual describing the recovery procedure which will be circulated to customers. This action has been closed-out o 08/08/2016. |
| Contact Information |
02 9466 2600 - FUJIFILM Australia Pty Ltd |