FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips Ingenia Ambition MRI systems recalled for incorrect brain imaging data export

OTHERNationwide distributionMedical devices

What this means

Certain Philips Ingenia Ambition 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 the Enhanced MR DICOM format. When this flawed data is processed by third-party software designed to map nerve pathways in the brain, the software cannot correctly reconstruct the imaging results.

If you operate an affected MRI system, contact Philips North America to identify your system's serial number against the recall list
Do not export DTI scans in Enhanced MR DICOM format until you receive guidance from Philips
Check the Philips service bulletin for software updates or alternative export methods

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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

422

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3310-2026

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 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
FDA-Device2026-10-07
Philips MR 5300 MRI system recalled for incorrect DTI scan export data

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