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MR 5000 Series

Philips Medical Systems Nederland B.V. · Model MR 5300 · UDI-DI 00884838112841

LNH Prescription

510(k) clearances

4,787

Adverse events (37 deaths)

723

Recalls

148

Facilities

Description

Philips innovative MR 5300 magnetic resonance imaging system simplifies and automates the most complex clinical and operational tasks. So you can create highly personalized exams of even your most challenging patients. Quickly. Easily. Intelligently. Smart Workflow reduces the number of steps needed to complete an MR exam and enables guided patient set-up in under a minute, the ultra-lightweight and flexible Breeze coils help cut patient change-over time by 30% to keep your MR department on schedule. At the same time, they improve patient comfort and staff satisfaction. This will help you meeting the challenging demands of productivity and patient throughput at private clinics and diagnostic imaging centers. MR 5300 is not only a fast MR, but also smart and flexible, providing intelligent tools for fast exams and quality scanning.

Recalls

Date	Firm	Reason
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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
2026-08-28	Philips North America	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.