Philips North America: System, Nuclear Magnetic Resonance Imaging

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.

Tags

FDA recall, medical device, class 2, Radiology, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 2: Information Security Risk Management; CISA 2: Governance and Management of IT; CISA 3: Information Systems Acquisition, Development and Implementation

Source record id

Z-3310-2026

First seen by InfoSec Signals

10/9/2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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