FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips MR 7700 MRI system recalled for incorrect DTI export data in Enhanced DICOM format

OTHERNationwide distributionMedical devices

What this means

Certain Philips MR 7700 MRI systems (software versions R11, R12, R13) export diffusion tensor imaging (DTI) scans with incorrect directional information when using Enhanced MR DICOM format. When this data is processed by third-party brain mapping software, the software cannot correctly reconstruct the nerve fiber pathways.

If you operate a Philips MR 7700 system with the affected serial numbers, contact Philips for a software upgrade
Do not use Enhanced MR DICOM exports from affected systems for clinical tractography or nerve mapping until upgraded
Contact Philips North America for instructions on applying the corrective software update

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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

Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3317-2026

More Philips recalls

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Philips Ingenia Elition MRI systems recalled for incorrect DTI scan exports
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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
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Philips SmartPath to MR 7700 recalled for incorrect DTI export data in brain imaging
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Philips MR 5300 MRI system recalled for incorrect DTI scan export data

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