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Shielded Interface Unit
Nordicneurolab AS · Model SIU 2.0 · UDI-DI 07090042055024
10
510(k) clearances
4,751
Adverse events (37 deaths)
723
Recalls
146
Facilities
Description
Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system
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.