FDA Device recall Z-3311-2026
Ingenia Elition S and Ingenia Elition X
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Ingenia Elition S and Ingenia Elition X by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3311-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-28 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
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.
Identifiers
| code_info | 1. Model number (REF): 781357 (S); UDI-DI: 00884838088108; Serial Numbers: 46002, 46012, 46013, 46017, 46018, 46020, 46…1. Model number (REF): 781357 (S); UDI-DI: 00884838088108; Serial Numbers: 46002, 46012, 46013, 46017, 46018, 46020, 46021, 46023, 46025, 46027, 46029, 46036, 46039, 46041, 46042, 46044, 46053, 46054, 46082, 46086, 46092; 2. Model Number (REF): 782106 (S); UDI-DI: 00884838098329; Serial Numbers: 46203, 46204, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46243, 46249, 46258, 46269, 46270, 46286, 46302, 46315, 46325, 46375; 3. Model Number (REF): 782137 (S); UDI-DI: 00884838108615; Serial Numbers: 64001, 64002, 64003, 64004, 64005, 64014, 64015, 64029, 64032, 64039, 64040, 64041, 64042, 64049, 64050, 64051, 64052; 4. Model Number (REF): 782157 (S); UDI-DI: 00884838115682; Serial Numbers: 8900, 89003; 5. Model Number (REF): 781358 (X); UDI-DI: 00884838088115; Serial Numbers: 45008, 45009, 45010, 45011, 45024, 45026, 45028, 45029, 45032, 45033, 45034, 45035, 45036, 45037, 45040, 45041, 45046, 45048, 45049, 45054, 45055, 45056, 45060, 45062, 45066, 45070, 45072, 45073, 45075, 45076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
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FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
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FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade dStream
FDA Device · Class II · 2026-10-07 · Philips North America
All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3311-2026%22
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