FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips SmartPath to MR 7700 recalled for incorrect DTI export data in brain imaging

OTHERNationwide distributionMedical devices

What this means

Philips SmartPath to MR 7700 systems (models 782178 and 782207, software versions R11–R13) export diffusion tensor imaging (DTI) brain scans with incorrect data when using the Enhanced MR DICOM format. When this faulty data is processed by third-party tractography software used for mapping nerve fiber pathways, the software cannot correctly reconstruct the brain images.

Contact Philips if your facility operates a SmartPath to MR 7700 system with the affected model and serial numbers
Do not use Enhanced MR DICOM exports from affected systems for clinical tractography without consulting Philips
Watch for instructions from Philips regarding software updates or corrective measures

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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

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3315-2026

More Philips recalls

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

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