Draeger Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (4 Class I)
- 510(k) Clearances
- 48
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1066-2025 | Class II | Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for | January 14, 2025 |
| Z-2189-2024 | Class II | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Re | May 13, 2024 |
| Z-1992-2023 | Class II | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C | May 16, 2023 |
| Z-1472-2023 | Class II | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulator | April 5, 2023 |
| Z-1471-2023 | Class II | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patie | April 5, 2023 |
| Z-1365-2022 | Class II | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport sy | May 20, 2022 |
| Z-2047-2018 | Class I | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s of | May 15, 2018 |
| Z-2046-2018 | Class I | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s o | May 15, 2018 |
| Z-1440-2014 | Class I | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 | March 5, 2014 |
| Z-1298-2014 | Class I | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), | February 7, 2014 |
| Z-0714-2014 | Class II | Draeger Infinity Acute Care System Monitoring Solution | December 10, 2013 |
| Z-1950-2012 | Class II | Drager PT 4000 Phototherapy System | July 2, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243606 | Babyroo TN300 | January 17, 2025 |
| K240312 | Infinity CentralStation Wide | August 1, 2024 |
| K233834 | Infinity Gateway Suite | July 12, 2024 |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | October 17, 2023 |
| K230278 | Babyroo TN300 | May 30, 2023 |
| K203579 | Infinity Gateway Suite | June 7, 2022 |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | February 1, 2022 |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | December 9, 2021 |
| K200859 | Infinity M300 | August 28, 2020 |
| K182977 | Isolette 8000 Plus | November 21, 2018 |
| K172656 | BiliLux | May 1, 2018 |
| K151860 | Infinity CentralStation Wide | September 2, 2015 |
| K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION | December 12, 2014 |
| K133175 | DRAEGER JAUNDICE METER JM-105 | November 13, 2014 |
| K141565 | GLOBE-TROTTER GT5400 | September 10, 2014 |
| K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 | April 11, 2013 |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | November 2, 2012 |
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET | March 22, 2012 |
| K113206 | NANOBLUTM 500 | February 17, 2012 |
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE | October 6, 2011 |