Draeger Medical Systems recalls

5 official recalls and safety alerts involving Draeger Medical Systems since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Draeger Medical Systems or the relevant agency.

  1. 2025-02-05
  2. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult,…

    Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

    FDA · DeviceDraeger Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO,…Official notice →
  3. 2024-07-03
  4. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

    Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and…

    FDA · DeviceDraeger Medical Systems, Inc.US Nationwide distribution. International distribution to Afghanistan,…Official notice →
  5. 2023-06-28
  6. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C,…

    The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

    FDA · DeviceDraeger Medical Systems, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL,…Official notice →
  7. 2023-05-03
  8. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and…

    The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow…

    FDA · DeviceDraeger Medical Systems, Inc.Worldwide - US Nationwide distribution.Official notice →
  9. 2022-07-20
  10. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

    The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

    FDA · DeviceDraeger Medical Systems, Inc.No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT,…Official notice →