Gloucester, GB · 12 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2026-03-12 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Class II | Cardiovascular | 2 | 2025-08-04 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2021-05-04 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2026-03-12 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2024-07-18 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2024-05-31 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2022-05-06 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2020-10-02 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2020-04-13 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-19 | Class II | Ongoing | Z-1696-2025 | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia D… | — | Medical device software marketed without FDA clearance . |
| 2025-03-19 | Class II | Ongoing | Z-1695-2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or … | — | Medical device software marketed without FDA clearance . |
| 2025-01-16 | Class II | Ongoing | Z-1327-2025 | Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulm… | — | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. |
| 2023-03-13 | Class II | Completed | Z-0224-2025 | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c… | — | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-12 | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | DTR | Class II | Cardiovascular |
| 2026-03-12 | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | DTZ | Class II | Cardiovascular |
| 2025-08-04 | K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | KFM | Class II | Cardiovascular |
| 2025-07-08 | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | DTR | Class II | Cardiovascular |
| 2025-06-24 | K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | KFM | Class II | Cardiovascular |
| 2024-07-18 | K241206 | Quantum Perfusion Hybrid System | DTN | Class II | Cardiovascular |
| 2024-05-31 | K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | DWF | Class II | Cardiovascular |
| 2022-05-06 | K212657 | Quantum Heater-Cooler | DWC | Class II | Cardiovascular |
| 2021-05-04 | K210669 | Quantum Mini Ventilation Module | DTX | Class II | Cardiovascular |
| 2020-10-16 | K202733 | Quantum Ventilation Module | DTX | Class II | Cardiovascular |
| 2020-10-02 | K202557 | Quantum Workstation 12 Elite | DRY | Class II | Cardiovascular |
| 2020-04-13 | K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | DWA | Class II | Cardiovascular |