Munich, DE · 7 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | Class II | Cardiovascular | 3 | 2023-08-24 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2022-11-16 |
| DXJ | Display, Cathode-Ray Tube, Medical | Class II | Cardiovascular | 1 | 2021-11-10 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2021-04-01 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-10-18 | Class II | Ongoing | Z-0571-2025 | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | — | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backu… |
| 2023-08-03 | Class II | Ongoing | Z-0073-2024 | 3T Heater Cooler System, REF: 16-02-85 | — | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. |
| 2021-12-17 | Class III | Terminated | Z-0787-2022 | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst… | — | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-08-24 | K232291 | Essenz HLM, Essenz ILBM | DTQ | Class II | Cardiovascular |
| 2023-03-09 | K221373 | Essenz HLM | DTQ | Class II | Cardiovascular |
| 2022-11-16 | K220635 | Heater-Cooler System 3T | DWC | Class II | Cardiovascular |
| 2021-11-10 | K212003 | ESSENZ Patient Monitor | DXJ | Class II | Cardiovascular |
| 2021-04-05 | K210130 | Stockert S5 System | DTQ | Class II | Cardiovascular |
| 2021-04-01 | K202154 | B-Capta | DRY | Class II | Cardiovascular |
| 2020-02-25 | K191402 | Heater-Cooler System 3T | DWC | Class II | Cardiovascular |