FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips MR 7700 MRI system recalled for incorrect diffusion tensor imaging export data

OTHERNationwide distributionMedical devices

What this means

Certain Philips MR 7700 MRI systems export diffusion tensor imaging (DTI) brain scans with incorrect directional data when using the Enhanced MR DICOM format. This error can prevent third-party software from correctly reconstructing fiber tract maps used to plan brain surgery and diagnose neurological conditions.

If you operate or manage an affected MRI system, contact Philips North America for a software update or corrective instructions.
Do not rely on DTI exports from affected systems for clinical decision-making until the issue is resolved.
Check your system's model number (782120, 782153, 782155, or 782199) and software version (R11, R12, or R13) against the serial numbers listed in the official FDA notice.

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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

107

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3313-2026

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
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

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