| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00084-1 |
| Product Name/Description |
Allura Xper, Allura Centron, and Azurion Systems
Multiple product and model numbers
ARTG 370112
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Three (3) components of the PCs may not perform as intended due to manufacturing problems.
Component 1: DIMM (Dual In-line Memory Modules)
Impact: System may stop functioning and imaging may not be possible.
Component 2: Disk Bay
Impact: System may stop functioning and imaging may not be possible.
Component 3: Framegrabber Card
Impact: FlexVision monitor may show no viewports, or one or more viewport may show no image, a distorted image, or a frozen image. Switching viewports on the monitor may not be possible.
A cold restart of the system may temporarily resolve the problem.
The malfunction might cause a loss of key imaging and result in a delay or termination of the procedure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will be replacing the three (3) components in all affected systems. Component replacements will be prioritized to those customers that have experienced or may be experiencing a component issue, followed by age of the PC. Philips will contact customers to schedule a visit to replace the affected components (reference 2023-IGT-BST-027).
Philips anticipates to release the corrections by Q2 2024. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |