Philips MRI Scanners and Upgrade Kits
Ingenia Blue Seal SE and Blue Seal XE export incorrect diffusion data when using Enhanced MR Dicom format.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Philips North America recalled multiple MR systems, including the Ingenia Blue Seal SE and Blue Seal XE, because when exporting diffusion tensor imaging (DTI) scans using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the export is used with third-party software for tractography, such as mapping nerve fiber pathways in the brain, the software will not correctly process the DTI data for reconstruction. The recall began August 28, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838104402
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838099364
- 00884838112841
- 00884838115675
- 00884838128446
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838055339
- 00884838009813
- 00884838098299
- 00884838068452
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838105591
Product details
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;- UDI-DI
- 00884838088108
- 00884838098329
- 00884838108615
- 00884838115682
- 00884838088115
- 00884838098336
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838125698
- 00884838128422
Product details
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X;
Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X);
Software Versions: R11, R12 and R13;- UDI-DI
- 00884838095076
- 00884838098886
- 00884838108691
- 00884838115767
- 00884838108684
- 00884838115750
- 00884838095083
- 00884838098909
- 00884838105805
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838122239
- 00884838128576
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
- UDI-DI
- 00884838104112
- 00884838112858
- 00884838115668
- 00884838128439
Product details
Ingenia 1.5T, 1.5T CX, and 1.5T S;
Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S);
Software Versions: R11, R12 and R13;- UDI-DI
- 00884838099715
- 00884838055322
- 00884838009820
- 00884838099043
- 00884838108646
- 00884838068445
Product details
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;- UDI-DI
- 00884838090057
- 00884838098343
- 00884838108639
- 00884838115705
- 00884838128477
- 00884838090040
- 00884838098350
Product details
Evolution upgrade 1.5T amd Evolution upgrade 3.0T;
Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T);
Software Versions: R11, R12 and R13;- UDI-DI
- 00884838099722
- 00884838108714
- 00884838115774
- 00884838128552
- 00884838099739
- 00884838108660
- 00884838115736
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99834
- Recall numbers
- Z-3307-2026 to Z-3318-2026
- Company
- Philips North AmericaCambridge, Massachusetts
- Hazard
- Software defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
