| TGA Action ID |
RC-2026-RN-00717-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Certain Philips MR Systems with Diffusion Tensor Imaging (DTI)
Software Versions: R11, R12, & R13
Ingenia 1.5T
Models: 781341, 781396
Ingenia 3.0T
Models: 781342, 781377
Ingenia 3.0T CX
Model: 781271
Ingenia Ambition 1.5T X
Model: 781356
Ingenia Elition S 3.0T
Model: 781357
Ingenia Elition X 3.0T
Model: 781358
Ingenia Elition S
Model: 782106
MR 7700
Models: 782120, 782155 |
| ARTG Number |
230064, 372370, 485786 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When exporting diffusion tensor imaging (DTI) scans from a Philips MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
If an incorrect reconstruction image is used for treatment planning, it may lead to inadequate or inappropriate treatment. As of August 2026, there have been 2 complaints associated with this problem, with no reports of injury or adverse events. |
| Instructions for Customers/Users |
Philips will contact customers to schedule a software upgrade to fix the problem.
In the interim, customers may continue to use their systems in accordance with the intended use. To prevent the problem from occurring, customers will need to use the Classic DICOM transfer option for exporting DTI scans, per the instructions in the Customer Letter. |
| Action Commencement Date |
21/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |