| TGA Action ID |
RC-2026-RN-00539-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Allura R8.2 Systems, equipped with any AD7x patient table
Allura Xper FD10
Model: 722026
Allura Xper FD10/10
Model: 722027
Allura Xper FD20
Model: 722028
Allura Xper FD20/15
Model: 722058 |
| ARTG Number |
225815 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
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 tables of Allura R8.2 systems. When the problem occurs, no message is displayed to the user. In this situation, X-ray imaging is available. The problem can be resolved by performing a cold restart of the system or by restarting the geometry.
Philips has not received reports of harm associated with this problem on the devices in scope of this correction. |
| Instructions for Customers/Users |
If the problem occurs, customers are to restart the geometry following the steps described in the Instructions for Use and customer letter. A geometry restart may take up to 2 minutes to complete.
Philips will correct affected systems by implementing a software update (R8.2.102.1). Philips currently expects R8.2.102.1 to be available by Q1 2027, subject to regulatory clearance.
Your local Philips representative will contact you to schedule a visit for the implementation of the software update once it becomes available. |
| Action Commencement Date |
22/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |