| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00424-1 |
| Product Name/Description |
DuraDiagnost 3.0/4.0 X-ray system
Product numbers 712211, 712214
Multiple lot numbers
ARTG Number: 207424 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
The system is designed to emit an acoustic signal (beep) upon termination of an exposure. However, if the system has been powered on for more than 12 hours, the system will no longer emit this signal. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips recommends that the system is rebooted at least every 11 hours until the software is upgraded. A Philips service engineer will contact the customers to implement the software upgrade to release 02.3400.015. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |