FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips Ingenia Blue Seal MRI systems recalled for incorrect diffusion imaging data export

OTHERNationwide distributionMedical devices

What this means

Philips Ingenia Blue Seal SE and XE MRI systems running software versions R11, R12, or R13 export diffusion tensor imaging (DTI) scans with incorrect directional data when using the Enhanced MR DICOM format. This faulty data may prevent third-party brain tractography software from correctly reconstructing nerve fiber pathway maps.

Check if your Ingenia system is model 782185 (SE) or 782192 (XE) with software R11, R12, or R13
Contact Philips for software updates or guidance on DTI exports
Do not use Enhanced MR DICOM DTI exports from affected systems for clinical tractography analysis until remediated

Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓

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

Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3307-2026

More Philips recalls

FDA-Device2026-10-07
Philips MR 7700 MRI system recalled for incorrect DTI export data in Enhanced DICOM format
FDA-Device2026-10-07
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 SmartPath to MR 7700 recalled for incorrect DTI export data in brain imaging
FDA-Device2026-10-07
Philips MR 5300 MRI system recalled for incorrect DTI scan export data

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.