FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips Ingenia Elition MRI systems recalled for incorrect DTI scan exports

OTHERNationwide distributionMedical devices

What this means

Philips Ingenia Elition S and X MRI systems running software versions R11, R12, or R13 export brain diffusion tensor imaging (DTI) scans with incorrect directional data when using Enhanced MR DICOM format. This error can prevent third-party brain mapping software from correctly processing the scans.

Check your MRI system model and serial number against the recall list
Contact Philips North America for a software update or corrective action
Do not use Enhanced MR DICOM exports for DTI tractography until 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

Adults

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

340

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3311-2026

More Philips recalls

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Philips MR 7700 MRI system recalled for incorrect DTI export data in Enhanced DICOM format
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Philips Ingenia Blue Seal MRI systems recalled for incorrect diffusion imaging data export
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Philips MR 5300 MRI system recalled for incorrect DTI scan export data

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