| TGA Action ID |
RC-2026-RN-00607-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Azurion R2.x.10, R3.0, R3.1 and R4.0 systems
Model Numbers: 722067, 722068, 722078, 722079, 722221, 722223, 722224, 722226, 722227, 722228, 722233, 722234, 722236 |
| ARTG Number |
225815, 370112 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified 2 potential problems that may lead to delay of therapy, procedural complications and/or inappropriate treatment.
• Problem 1: Image quality degradation
A problem associated with the Flat Detector Controller System Interface Board (FDCSIB), may result in image artifacts during system operation. The observed artifacts may include black and white dot noise, grainy or cloudy image quality, snow-like effects, and random pixelation.
• Problem 2: Loss of geometry movements – Applicable to systems with an AD7X table only
In some cases, following a system (re)start, manual and motorised geometry movements may be disabled due to a firmware problem in the Advanced Motion Controller (AMC) single-axis motion control unit used in the AD7X table of Azurion systems. When the problem occurs, no message is displayed to the user. In this situation, X-ray imaging remains available. |
| Instructions for Customers/Users |
Customers should note:
· Problem 1: Image quality degradation
If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions for Use/ customer letter:
NOTE: A cold restart of the system takes up to 6 minutes from initiation of the cold restart until all system functionality is available.
· Problem 2: Loss of geometry movements
If loss of geometry movements is observed, restart the geometry following the steps described in the Instructions for Use/ customer letter:
NOTE: A geometry restart may take up to 2 minutes to complete.
Philips is developing software updates to address the problem in each affected software version. The anticipated start date of the correction for each software release is outlined in the customer letter however varies from August 2026 to March 2027, subject to regulatory clearance. |
| Action Commencement Date |
10/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team. |