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Draeger Medical Recalls
78 recalls on record · March 20, 2013 to December 25, 2024 · 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.
May 16, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machine
Hazard: 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.
May 16, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines
Hazard: 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.
May 16, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia mac
Hazard: 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.
May 16, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines f
Hazard: 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.
August 10, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pedia
Hazard: Isolated episodes of leakage at the check valve were found
August 3, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babythe
Hazard: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
June 1, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M367
Hazard: 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 Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
March 2, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Hazard: 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 batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
February 10, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965
Hazard: 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.
February 10, 2016Medical DevicesFDA
Draeger Medical, Inc. recalls Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and
Hazard: 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.
December 30, 2015Medical DevicesFDA
Draeger Medical, Inc. recalls Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a venti
Hazard: 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 patient transport will be a priority.
December 23, 2015Medical DevicesFDA
Draeger Medical, Inc. recalls Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and ca
Hazard: 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 failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
August 26, 2015Medical DevicesFDA
Draeger Medical, Inc. recalls PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and
Hazard: The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
August 5, 2015Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating,
Hazard: 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.
April 16, 2014Medical DevicesFDA
Draeger Medical, Inc. recalls Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesth
Hazard: 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 Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR . A
November 20, 2013Medical DevicesFDA
Draeger Medical, Inc. recalls Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Hazard: 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).
October 16, 2013Medical DevicesFDA
Draeger Medical, Inc. recalls Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia an
Hazard: 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.
March 20, 2013Medical DevicesFDA
Draeger Medical, Inc. recalls Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Ph
Hazard: 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 vertical position but upside down, or laying it on the floor or on the patient bed.