| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00470-1 |
| Product Name/Description |
MammoDiagnost DR with software release 2.1 (mammography system)
ARTG number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The dose exceeds levels set by local regulations in Sweden, New Zealand and Australia when Automatic Exposure Control (AEC) is used and the exposure time in magnification mode is too long. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are informed that the system can continue to be used according to the instructions for use. New software will be implemented to ensure compliance with local requirements. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |