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Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye

BAYER MEDICAL CARE INC. · Model SQK 65S · UDI-DI 00616258005515

LNH Prescription
1
510(k) clearances
4,751
Adverse events (37 deaths)
723
Recalls
146
Facilities

Description

MRI Integral ”T” with Check Valve for MEDRAD® Spectris MR Injector (Contents: 1 - 96" Low Pressure Connector Tube with T-Connector and Check Valve) (MR - SPECTRIS SYRINGE KIT, 2-65ML) (60728516)

Recalls

DateFirmReason
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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
2026-08-28Philips North AmericaWhen 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.