FDA-Device2026-10-07Class IIPROCESSING DEFECT

Philips Ingenia 3.0T MRI systems recalled for incorrect brain imaging data export

OTHERNationwide distributionMedical devices

What this means

Certain Philips Ingenia 3.0T and 3.0T CX MRI systems running software versions R11, R12, or R13 export brain diffusion imaging scans with incorrect directional data when using Enhanced MR DICOM format. When this corrupted data is processed by third-party brain mapping software, the software cannot properly reconstruct nerve pathway images.

If your facility operates an affected Philips Ingenia system, contact Philips immediately for a software update or corrective guidance
Do not use Enhanced MR DICOM exports from affected systems for clinical tractography analysis until the issue is resolved
Refer to the serial number list in the FDA notice to confirm if your device is affected

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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

243

Manufactured in

222 Jacobs St, Cambridge, MA, United States

Products

Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3309-2026

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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