Draegar Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1012-2022 | Class II | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring w | March 4, 2022 |
| Z-1104-2021 | Class II | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, ph | December 23, 2020 |
| Z-0372-2020 | Class II | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755 | October 9, 2019 |
| Z-0258-2020 | Class II | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient | September 13, 2019 |
| Z-0974-2019 | Class II | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors | February 8, 2019 |
| Z-0975-2019 | Class II | Omega Systems These devices are intended to be used in the environment where patient care is prov | February 8, 2019 |
| Z-1813-2018 | Class II | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS | March 28, 2018 |
| Z-1382-2018 | Class II | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, M | February 21, 2018 |
| Z-0942-2018 | Class II | INFINITY DUAL HEMO MCable Pod | October 4, 2017 |
| Z-2734-2017 | Class II | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722 | June 6, 2017 |
| Z-1772-2017 | Class II | Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Ox | March 28, 2017 |
| Z-1774-2017 | Class II | Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Ox | March 28, 2017 |
| Z-1773-2017 | Class II | Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four | March 28, 2017 |