| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00200-1 |
| Product Name/Description |
Philips DigitalDiagnost, ProxiDiagnost, and CombiDiagnost systems
DigitalDiagnost reference numbers (r#): 712031, 712032, 712033, 712084, 712034, 712035, 712234, 712235
ProxiDiagnost r#: 709030, 709031
CombiDiagnost r#: 706100, 706110
ARTGs 346498, 283084 and 340852 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/03/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips are advising that the system audio signal will be disabled, and no sound will be present when an exposure is terminated if the user follows either of the below sequences involving switching the system to STANDBY. The exposure image will still appear on the monitor even though there is no sound.
Scenario 1:
User switches off the system using OFF button (button number 2 in figure 1).
User presses the STANDBY button (button number 6 in figure 1). LED status will turn on to orange.
User switches on the system using ON button (button number 1 in figure 1) but does not push the STANDBY button.
Scenario 2:
User presses the STANDBY button. LED status will turn on to orange.
User switches off the system using OFF button.
User switches on the system using ON button but does not push the STANDBY button.
There have been no adverse events reported to Philips as of December 2022. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to follow the instructions in the IFU. This includes ensuring users are turning the system ON/OFF using the recommended sequence in the IFU section titled “Switching the System ON/OFF”. If the STANDBY button is pressed the monitor may go into Standby Mode, which results in disabling the audible sound output. The audible sound output can be re-enabled by pressing the STANDBY button again.
Users are requested to attach the customer letter (supplied to impacted facilities by the sponsor) as an addendum to the IFU provided with the system for awareness and reference. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |