Spectrum Medical Ltd.

FDA Regulatory Profile

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
23
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1696-2025Class IIBrand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (March 19, 2025
Z-1695-2025Class IIBrand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without ArrhMarch 19, 2025
Z-1327-2025Class IIBrand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: PumJanuary 16, 2025
Z-0224-2025Class IIQuantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the vMarch 13, 2023
Z-2238-2019Class IQuantum Pump ConsoleMay 29, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WMarch 12, 2026
K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VMarch 12, 2026
K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)August 4, 2025
K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)July 8, 2025
K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)June 24, 2025
K241206Quantum Perfusion Hybrid SystemJuly 18, 2024
K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)May 31, 2024
K212657Quantum Heater-CoolerMay 6, 2022
K210669Quantum Mini Ventilation ModuleMay 4, 2021
K202733Quantum Ventilation ModuleOctober 16, 2020
K202557Quantum Workstation 12 EliteOctober 2, 2020
K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureApril 13, 2020
K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)May 24, 2019
K181942Quantum Ventilation ModuleOctober 18, 2018
K181923Quantum Workstation 12.1August 17, 2018
K173834Quantum Pump ConsoleMay 25, 2018
K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasMarch 28, 2018
K163657Quantum WorkstationJanuary 18, 2017
K110957M4 MONITORMay 31, 2011
K091908M3 MONITORJuly 10, 2009