| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00479-1 |
| Product Name/Description |
FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)
Serial Number: 37020038
ARTG Number: 159785 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
It was found that for software V5.1.0001-0007 used in Workstation (AWS), which is a component of FUJIFILM Digital Mammography System, when image enhancement processing is performed on the exposed image with an option function during Biopsy, the screen may not return to the original image. Depending on the enhancement parameter, the calcification may seem unclear compared to the original image. Therefore, there is a potential that the tip of needle cannot reach the desired biopsy area. Furthermore, after collecting the target sample, it may be difficult to ascertain whether the necessary calcification part has been properly extracted. Due to these reasons, the occurrence of this issue may precipitate that a re-examination might be necessary. This image processing is an option for Biopsy and does not affect other normal exposures. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to not perform image enhancement during Biopsy. In the case that a calcification becomes unclear due to enhancement processing, select the weakest enhancement processing or redisplay the image on the 1st monitor by right-clicking. FUJIFILM service personnel will contact the affected facility to arrange for a software update as a corrective measure. |
| Contact Information |
02 9466 2600 - Fujifilm Australia Pty Ltd |