Recall Z-3310-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
| Date | Sep 25, 2026 (initiated Aug 28, 2026) |
| Status | Open, Classified |
| Reason | When exporting diffusion tensor imaging (DTI) scans from a 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. |
| Root cause | Software design |
| Action | On August 28, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. To prevent the issue from occurring while Philips is developing the software solution, use the Classic DICOM transfer option for exporting DTI scans. 2. You may continue to use your system(s) in accordance with the intended use. 3. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. 4. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is i |
| Quantity | 422 |
| Distribution | Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Gree |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Feb 14, 2019 |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., May 16, 2022 |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Philips Medical Systems Nederland B.V., Apr 6, 2023 |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System Philips Medical Systems Nederland B.V., Jun 4, 2025 |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ing Philips Medical Systems Nederland B.V., Jul 11, 2025 |