| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00072-1 |
| Product Name/Description |
DigitalDiagnost Release 4.0.0. and 4.0.1
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/01/2015 |
| 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 54 hours, the beep will no longer be emitted.
If the system does not provide the expected acoustic signal upon the completion of an exposure, the operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure resulting in unnecessary radiation being administered to the patient.
Until the system software is upgraded to release 4.0.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that users reboot the system every two days or less. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are alerted to this issue and provided with a workaround until a permanent software fix can be rolled out. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |