FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips Evolution MRI systems recalled for incorrect DTI scan data export

OTHERNationwide distributionMedical devices

What this means

Philips Evolution 1.5T and 3.0T MRI systems with software versions R11, R12, or R13 export diffusion tensor imaging (DTI) scans with incorrect diffusion direction data when using the Enhanced MR DICOM format. This incorrect data can prevent third-party tractography software from properly reconstructing brain nerve fiber pathway maps.

Check your MRI system model and serial number against the FDA notice to determine if your system is affected.
If you use Enhanced MR DICOM export with third-party tractography software, contact Philips for software correction or guidance before relying on DTI reconstructions.
Do not use affected system DTI exports for clinical tractography until the issue is resolved.

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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

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3318-2026

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 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
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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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