Philips North America recalls MR 5300

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.

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

On August 28, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. To prevent the issue from occurring while Philips is developing the software solution, use the Classic DICOM transfer option for exporting DTI scans. 2. You may continue to use your system(s) in accordance with the intended use. 3. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. 4. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed.

• FDA enforcement recordOfficial FDA database entry for Z-3312-2026
• FDA 510(k) clearance · K223442The device's official FDA premarket clearance record
• FDA 510(k) clearance · K223458The device's official FDA premarket clearance record
• FDA 510(k) clearance · K251397The device's official FDA premarket clearance record
• FDA 510(k) clearance · K251808The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North AmericaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.