| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00172-1 |
| Product Name/Description |
Uronav, Transperineal option - Stepper with Stand
(stereotactic accessory for use with clinical imaging systems)
Model Number: 980603113091
Serial Numbers 1, 2 or 3
ARTG Number: 230930 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
A problem has been detected in the Transperineal Stepper with Stand. The stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |