| TGA Action ID |
RC-2026-RN-00559-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CombiDiagnost R90, DigitalDiagnost 4, DigitalDiagnost C90, and ProxiDiagnost N90
CombiDiagnost R90
Model: 709031
Version: 1.1.7V08.4270.006
DigitalDiagnost 4 Flex / Value
Model: 712028
Version: 4.3.2V18.4270.005
DigitalDiagnost 4 High Performance
Model: 712031
Version: 4.3.2V18.4270.005
DigitalDiagnost C90 High Performance
Model: 712034
Version: 1.1.7V20.4270.008 |
| ARTG Number |
117662, 340852, 390959 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following implementation of PSC 10.1, Philips identified several problems affecting DigitalDiagnost and ProxiDiagnost/ CombiDiagnost systems:
1. The system may not enter a ready state for wall stand exposures when the Ceiling Suspension Motorised (CSM) Arm Swing is not in the locked position, preventing certain examinations from being performed as intended.
2. The Tube Control Handle (TCH) may intermittently restart multiple times during start-up, resulting in delays before the system is available for clinical use.
3. Systems without a valid 2D camera licence may display the live camera image on the Acquired Work Station (AWS).
4. Following a language change, the TCH display may not immediately synchronise with the selected system language after restart.
5. The CSHeightOffset calculation used by the Smart Collimation Thorax (SCT) feature may be less accurate for source-to-image distances greater than 150 cm.
These problems may result in temporary delays, limited functionality, or display inconsistencies; however, clinical examinations can continue using alternative workflows where applicable. Philips will provide a software update to address these problems. |
| Instructions for Customers/Users |
Customers are to:
- Continue using the affected systems in accordance with the intended use until the software update is installed.
- Note that the final correction, consisting of a software update and physical kit, is planned for release from 31 August 2026. |
| Action Commencement Date |
6/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |