| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01180-1 |
| Product Name/Description |
MammoDiagnost DR
ARTG number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch engaged. If this occurs while the needle is inserted, it could lead to an unintended patient injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Service representative will contact affected customers to schedule a service visit where the safety switch will be modified. In the interim Philips is reminding end users of the safety instructions in the user manual and recommending that the switch be inspected before every biopsy. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |