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Disposable MRI Kit with Check Valve

BAYER MEDICAL CARE INC. · Model SQK 65VS · UDI-DI 00616258007779

LNH Prescription

510(k) clearances

4,713

Adverse events (37 deaths)

699

Recalls

144

Facilities

Description

Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike (KIT,SYR/SPIKE/T,65mL FLS,MRI,MC,CH) (60728559)

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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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.