Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 7...
FDA Device Recall #Z-3311-2026 - Class II, August 28, 2026
Recall Summary
| Recall Number | Z-3311-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 28, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 340 |
Product Description
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 for Recall
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.
Distribution Pattern
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, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.
Lot / Code Information
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, 45078, 45086, 45087, 45089, 45090, 45091, 45093, 45094, 45096, 45097, 45098, 45099, 45100, 45105, 45108, 45112, 45113, 45115, 45116, 45119, 45120, 45127, 45129, 45132, 45136, 45138, 45140, 45146, 45147, 45148, 45152, 45154, 45156, 45157, 45160, 45162, 45168, 45174, 45181, 45186, 45187, 45189, 45190, 45191, 45194, 45205, 45215, 45231, 45235, 45237, 45243, 45245, 45246, 45250, 45252, 45264, 45272, 45277, 45278, 45290, 45296, 45316, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45374, 45379, 45395, 45398, 45399, 45406, 45407, 45414, 45423, 45441; 6. Model Number (REF): 782107 (X); UDI-DI: 00884838098336; Serial Numbers: 45500, 45503, 45506, 45507, 45508, 45509, 45510, 45514, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45545, 45547, 45551, 45560, 45561, 45573, 45574, 45578, 45579, 45589, 45594, 62019, 62024, 62026, 62030, 62031, 62033, 62035, 62037, 62040, 62041, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62063, 62065, 62067, 62070, 62071, 62073, 62080, 62081, 62082, 62088, 62092, 62098, 62134, 62136, 62137, 62148, 62151, 62152, 62153, 62159, 62178, 62181, 62182, 62197; 7. Model Number (REF): 782119 (X); UDI-DI: 00884838104129; Serial Number: 66001; 8. Model Number (REF): 782136 (X); UDI-DI: 00884838108608; Serial Numbers: 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28521, 28524, 28525, 28526, 28527, 28528, 28529, 28532, 28533, 28535, 28536, 28538, 28540, 28542, 28543, 28544, 28546, 28547, 28548, 28549, 28550, 28555, 28558, 28559, 28560, 28563, 28564, 28565, 28566, 28568, 28572, 28573, 28576, 28577, 28579, 28581, 28583, 28585, 28586, 28587, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28604, 28605, 28608, 28611, 28612, 28613, 28614, 28615, 28616, 28618, 28619, 28623, 28625, 28628, 28629, 28630, 28631, 28632, 28635, 28636, 28638; 9. Model Number (REF): 782158 (X); UDI-DI: 00884838115699; Serial Numbers: 90001, 90002, 90004, 90006, 90007, 90010, 90011, 90015, 90016, 90017, 90018, 90023, 90024, 90027, 90036; 10. Model Number (REF): 782198 (X); UDI-DI: 00884838128460; Serial Numbers: 57003, 57004, 57005, 57009;
Other Recalls from Philips North America
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3313-2026 | Class II | MR 7700; Model number (REF): 1. 782120, 2. 782... | Aug 28, 2026 |
| Z-3308-2026 | Class II | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model numbe... | Aug 28, 2026 |
| Z-3314-2026 | Class II | SmartPath to dStream for 1.5T, SmartPath to dSt... | Aug 28, 2026 |
| Z-3309-2026 | Class II | Ingenia 3.0T and 3.0T CX; Model number (REF): ... | Aug 28, 2026 |
| Z-3318-2026 | Class II | Evolution upgrade 1.5T amd Evolution upgrade 3.... | Aug 28, 2026 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.