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Draeger Medical Systems Recalls
12 recalls on record · July 18, 2012 to February 5, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 5, 2025Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor
Hazard: 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.
July 3, 2024Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Hazard: 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.
June 28, 2023Medical DevicesFDA
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
Hazard: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
May 3, 2023Medical DevicesFDA
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
Hazard: 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 amplitudes intermittently lower than actual.
May 3, 2023Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h
Hazard: 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 amplitudes intermittently lower than actual.
July 20, 2022Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Hazard: 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.
June 13, 2018Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physic
Hazard: Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
June 13, 2018Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physi
Hazard: Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
April 16, 2014Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Hazard: 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.
April 9, 2014Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or
Hazard: 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.
January 22, 2014Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Draeger Infinity Acute Care System Monitoring Solution
Hazard: 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.
July 18, 2012Medical DevicesFDA
Draeger Medical Systems, Inc. recalls Drager PT 4000 Phototherapy System
Hazard: 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 possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b