FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips MR 5300 MRI system recalled for incorrect DTI scan export data

OTHERNationwide distributionMedical devices

What this means

Philips MR 5300 MRI systems may export diffusion tensor imaging (DTI) scans with incorrect diffusion direction data when using Enhanced MR DICOM format. This can cause third-party tractography software to fail to correctly reconstruct brain nerve fiber pathway maps from the exported scans.

Check if your facility operates a Philips MR 5300 with software versions R11, R12, or R13
Do not use Enhanced MR DICOM exports from affected systems for clinical tractography until a remedy is available
Contact Philips for instructions on software updates or corrective actions
Review any DTI scans already exported and processed with this method for accuracy

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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

131

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3312-2026

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 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
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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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