| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00736-1 |
| Product Name/Description |
DigitalDiagnost, Release 4.1/4.1.1
(Digital diagnostic X-Ray system)
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2015 |
| 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. If this occurs, the system operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips plans to install a software upgrade (i.e., Release 4.1.2) in affected systems, which will eliminate this issue. A Philips Service Engineer will contact affected customers when the Field Action Kit is available to be implemented. Until the system software is upgraded to release 4.1.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that the system is rebooted at least every 11 hours. This action has been closed-out on 22/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |