| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00925-1 |
| Product Name/Description |
DuraDiagnost X-ray systems
ARTG Number: 207424 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
DuraDiagnost systems provide an audible exposure termination signal (Beep) through the speaker integrated into the monitor. However, buttons or keys on the monitor allow the user to turn the volume setting down to “0”, in which case the beep will not be heard at the conclusion of an exposure. Note that the current volume setting is displayed when the buttons or keys are depressed. If the monitor volume is set to “0”, the absence of an audible exposure termination signal may lead the operator to assume that an exposure was not performed correctly and therefore unnecessarily repeat the patient exposure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to check the volume of the monitor to ensure it is not set to '0'. Philips will be implementing a software upgrade as a permanent correction.
This action has been closed-out on 19/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |