Devices/Recall·openFDA/device

Philips North America — Class II: Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 7821

MediumPublished Oct 7, 2026· AI-analyzed Oct 13, 2026View original FDA source

AI-generated regulatory interpretation. The four sections below are an analyst-style summary produced by an AI model from the original FDA source. Always verify against the source before any regulatory, clinical, or commercial decision.

What happened

Philips North America has initiated a Class II recall for Ingenia 3.0T and 3.0T CX MR systems due to incorrect diffusion direction data in Enhanced MR DICOM exports. This data corruption prevents third-party software from accurately processing DTI data for tractography and nerve fiber reconstruction.

Who it affects

Users of Philips Ingenia 3.0T and 3.0T CX systems (REF 781342, 781377, 782103, 781271) running software versions R11, R12, and R13, specifically involving radiology departments and neurosurgery planning teams using third-party tractography tools.

Why it matters

This recall highlights a critical interoperability failure between diagnostic imaging hardware and third-party analysis software. The incorrect export of diffusion directions poses a risk to the integrity of surgical planning or diagnostic mapping of brain nerve fibers. From a regulatory perspective, this emphasizes the need for robust verification of DICOM export formats across multiple software versions during the development and post-market phases.

Practical takeaway

Identify and quarantine the affected software versions (R11, R12, R13) for these specific models. Advise clinical users to avoid using Enhanced MR DICOM exports for DTI tractography in third-party software until a patch is implemented. Verify historical data integrity for any nerve fiber mapping studies conducted using these exports.

FDA source material

Class II. Reason: 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.. Product: 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;. Firm: Philips North America (Cambridge MA United States). Status: Ongoing.

Open in openFDA / FDA.gov

AI-generated interpretation. Always verify critical decisions against the original FDA source. Generated with google/gemini-3-flash-preview.

Philips North America — Class II: Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 7821

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