Home › BAYER MEDICAL CARE INC. › MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
BAYER MEDICAL CARE INC. · Model SIT 96V · UDI-DI 00616258007380
1
510(k) clearances
4,713
Adverse events (37 deaths)
699
Recalls
144
Facilities
Description
Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes (SET,PKG,INTEG T/CV,MRI SIT 96V,RAD,MC,LA) (60728931)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
| 2026-04-14 | Philips North America | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction |
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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.