FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips SmartPath MRI software recalled for incorrect DTI export data

OTHERNationwide distributionMedical devices

What this means

Philips SmartPath software for certain MRI systems exports diffusion tensor imaging (DTI) scans with incorrect diffusion direction data when using Enhanced MR DICOM format. When this data is processed by third-party tractography software for brain nerve fiber mapping, the software cannot correctly reconstruct the images.

Check if your MRI system uses one of the affected SmartPath models (1.5T, 3.0T, XR, or Ingenia Elition X) with software versions R11, R12, or R13.
If affected, contact Philips North America for updated software or corrective instructions.
Do not rely on DTI tractography reconstructions from Enhanced MR DICOM exports until your system is corrected.

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The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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.

Affected count

200

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3314-2026

More Philips recalls

FDA-Device2026-10-07
Philips MR 7700 MRI system recalled for incorrect DTI export data in Enhanced DICOM format
FDA-Device2026-10-07
Philips Ingenia Elition MRI systems recalled for incorrect DTI scan exports
FDA-Device2026-10-07
Philips Ingenia Ambition MRI systems recalled for incorrect brain imaging data export
FDA-Device2026-10-07
Philips Ingenia Blue Seal MRI systems recalled for incorrect diffusion imaging data export
FDA-Device2026-10-07
Philips SmartPath to MR 7700 recalled for incorrect DTI export data in brain imaging

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