15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD
FDA Enforcement
Class II
·Ongoing·YAMAHA MOTOR CORPORATION·May 29, 2024
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 19, 2023
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·August 14, 2024
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·December 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·December 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·December 30, 2020
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 19, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·February 9, 2022
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·August 28, 2024