Recall Z-3239-2026 · LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
| Date | Sep 18, 2026 (initiated Aug 21, 2026) |
| Status | Open, Classified |
| Reason | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. |
| Root cause | Software design |
| Action | On August 24, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " To prevent this issue from occurring, o Use the standard 3D Vane scan protocol from the Philips Examcard Database, or o For custom 3D Vane scan protocols, use a maximum of 480 for the reconstruction matrix and use a maximum of 167 for the number of slices. " You may continue to use affected systems in accordance with their intended use. " Circulate this notice to all users or new owners of this device so that they are aware of the issues and associated hazard/harm. " Please retain this Ur |
| Quantity | 596 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D' |
| 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 |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei Philips Medical Systems Nederland B.V., Mar 3, 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 |
| K230972 | Ingenia Elition and MR 7700 MR Systems Philips Medical Systems Nederland B.V., Apr 28, 2023 |
| 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 |