FDA-Device2026-10-07Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

Philips dStream MR systems (model 782127, software versions R11–R13) export diffusion tensor imaging (DTI) scans with incorrect diffusion direction data when using the Enhanced MR DICOM format. When this exported data is processed by third-party tractography software used for brain nerve fiber mapping, the software cannot correctly reconstruct the DTI images.

If you operate this MR system and export DTI scans in Enhanced MR DICOM format, contact Philips for a software update or corrective instructions.
Do not rely on DTI reconstructions from Enhanced MR DICOM exports until you receive and install the remedy.
Contact Philips North America technical support for guidance on your specific system.

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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 dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3316-2026

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

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