| TGA Action ID |
RC-2025-RN-00516-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MR systems with SW versions R11.1 and R12.1
Multiple product codes |
| ARTG Number |
230064 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified potential alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application.
The cross-reference line and/or box may be shown at an incorrect location when displayed on a MobiView generated image.
The alignment errors may occur only if both of the following conditions are met:
·Multi-station scans that require stitching 3 or more station images, and
·Scan protocol is used where stations have different voxel size or field of view.
The cross-reference box of a MobiView generated image may be shown at an incorrect location when mirrored on to another image and if:
·The MobiView images are acquired with reversed slice scan order, or
·Displaying the cross-reference box of a MobiView generated merged series, or
·Displaying the cross-reference box of multi-planar reformats generated from multi-stack data.
Update 3/6/2026: Updated to include additional systems. Please note that Models not impacted by this problem in Australia have been removed.
The current impacted MR systems can be identified by the model name, model number (REF), and software version which are included in the customer letter.
As of May 2026, Philips has received no reports of adverse events associated with these problems. |
| Instructions for Customers/Users |
Customers are to:
- Continue to use their system(s) in accordance with the intended use.
- Avoid the potential problem of an incorrect cross reference line in MobiView generated images, by using the same voxel size and field of view across all station scans.
- Not use cross reference line functionality in box mode, all slices mode, or 3D mode.
They should only use the cross-reference line functionality in single slice mode.
A Philips representative will contact affected customers to schedule time for a Field Service Engineer to install a software upgrade to resolve the problems.
This action has been closed out on 01/10/2026 |
| Action Commencement Date |
30/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |