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Extremity L MR Coil Kit
Siemens Shenzhen Magnetic Resonance Ltd. · Model 10019205 · UDI-DI 04056869049601
3
510(k) clearances
4,751
Adverse events (37 deaths)
723
Recalls
146
Facilities
Description
Contains Medical Device Mat. 8635588 (GTIN:04056869038827)
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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Get your free API keyRead the docsData 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.