| TGA Action ID |
RC-2026-RN-00304-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips MR systems with MR Elastography (MRE)
Model Name: Ingenia 3.0T |
| ARTG Number |
230064 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Complaints have been reported regarding MR Elastography (MRE) stiffness measurements when specific image reconstruction parameters are used with Resoundant’s algorithm. The voxel size settings in the default scan protocol are too small and may result in underestimated liver stiffness values.
To date, no injuries or adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Continue to use MRE as per established clinical guidelines
- Manually update the scan protocol settings as described in the customer letter
Philips will provide updates and additional information as they become available. A representative will contact customers to schedule a Field Service Engineer to implement the software upgrade (ref: 2026-PD-MR-003), with an anticipated release date of 31 March 2027. |
| Action Commencement Date |
12/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |