| TGA Action ID |
RC-2026-RN-00284-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips AneurysmFlow
Software Versions: All |
| ARTG Number |
406592 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Mean Aneurysm Flow Amplitude (MAFA) ratio represents the volumetric flow rate quotient before and after neuro-interventional treatment in a cerebral aneurysm. Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment.
The Instructions for Use (IFU) of AneurysmFlow state that the MAFA ratio should not be used for making clinical decisions. In addition, when hovering over the MAFA ratio header within the software interface, an on-screen message states that the MAFA ratio is not to be used for clinical decision making. Despite the existing cautions, the displayed MAFA ratio may still be considered during intra-procedural decision-making and could influence clinical judgment. This may potentially result in an incorrect clinical decision.
To date, Philips has not received any complaints or reports of patient harm due to this problem. |
| Instructions for Customers/Users |
- Customers are not to use the MAFA ratio for clinical decision making as described in the IFU (Section 9.2).
- AneurysmFlow may continue to be used in accordance with the IFU.
- Philips is developing a software update to remove the MAFA ratio from AneurysmFlow.
- Philips expects to release this software update in December 2026. A local Philips representative will contact customers to schedule implementation of this software update once available. |
| Action Commencement Date |
21/04/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |