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 00616258024486
LNH
Prescription
1
510(k) clearances
4,713
Adverse events (37 deaths)
699
Recalls
144
Facilities
Description
ASSY,TUBE SET,SPECTRIS,96",MC,CORE (87622517)
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.