RegWardenFDA facility compliance records
Facility

DRAEGER MEDICAL SYSTEMS, INC.

40 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 3 recalls; 2014: 3 recalls; 2015: 5 recalls; 2016: 4 recalls; 2018: 5 recalls; 2019: 1 inspections; 2020: 1 warning letters; 2021: 4 recalls; 2022: 3 recalls, 1 inspections; 2023: 6 recalls; 2024: 4 recalls, 1 inspections; 2025: 1 recalls2’123’133’145’154’16’175’181’191’204’214’226’235’241’25’26
  • Recalls (40)
  • Inspections (3)
  • Warning letters (1)

Devices registered here (1)

Recalls & enforcement

20251 record
  • Class IIOngoing2025-01-14
    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.
20244 records
  • Class IOngoing2024-10-15
    The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
  • Class IOngoing2024-10-15
    The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
  • Class IIOngoing2024-05-13
    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 cardiac arrhythmia.
  • Class IOngoing2024-03-20
    Unexpected shutdown while operating on battery power.
20236 records
  • Class IOngoing2023-07-12
    Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
  • Class IOngoing2023-06-12
    Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
  • Class IIOngoing2023-05-16
    The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
  • Class ITerminated2023-04-17
    Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
  • Class IIOngoing2023-04-05
    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 and/or high frequency QRS may be displayed or printed with QRS…
  • Class IOngoing2023-01-23
    The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
20223 records
  • Class IIOngoing2022-05-20
    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.
  • Class IOngoing2022-05-16
    Possible occlusion of filters due to manufacturing error.
  • Class IITerminated2022-02-14
    Cybersecurity Improvement Action-not equipped against potential cyber security threats
20214 records
  • Class IITerminated2021-12-16
    26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation …
  • Class IIOngoing2021-09-10
    Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
  • Class IITerminated2021-04-16
    Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
  • Class IITerminated2021-01-29
    Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
20185 records
  • Class ITerminated2018-12-21
    Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
  • Class IITerminated2018-05-24
    The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
  • Class ITerminated2018-05-15
    Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
  • Class IITerminated2018-04-26
    The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
  • Class ITerminated2018-03-01
    The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
20164 records
  • Class IITerminated2016-06-22
    Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
  • Class ITerminated2016-05-31
    Isolated episodes of leakage at the check valve were found
  • Class IITerminated2016-04-21
    Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data …
  • Class ITerminated2016-02-04
    The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The ba…
20155 records
  • Class ITerminated2015-12-22
    Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
  • Class ITerminated2015-12-01
    The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for …
  • Class ITerminated2015-11-12
    There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failur…
  • Class ITerminated2015-07-13
    The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
  • Class IITerminated2015-06-22
    the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.
20143 records
  • Class IITerminated2014-03-25
    Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffe…
  • Class ITerminated2014-03-05
    The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
  • Class ITerminated2014-02-07
    The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
20133 records
  • Class IITerminated2013-12-10
    After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
  • Class IITerminated2013-09-30
    Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
  • Class ITerminated2013-08-14
    During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
20122 records
  • Class IITerminated2012-12-13
    The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vert…
  • Class IITerminated2012-07-02
    A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possibl…

FDA inspections (3)

  • NAI2024-11-27
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2022-04-21
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2019-09-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DRAEGER MEDICAL SYSTEMS, INC. (FEI 3005783425) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005783425-draeger-medical-systems-inc/

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