Draeger Medical recalls

Draeger Medical appears in 78 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of r…
  FDA Device · Class I · 2019-01-30 · Draeger Medical
  Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
• VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of…
  FDA Device · Class I · 2019-01-30 · Draeger Medical
  Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
• VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of…
  FDA Device · Class I · 2019-01-30 · Draeger Medical
  Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
• VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of res…
  FDA Device · Class I · 2019-01-30 · Draeger Medical
  Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
• Fabius GS Premium Anesthesia Machine
  FDA Device · Class II · 2018-06-27 · Draeger Medical
  Reason: 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. Potenti…
• Fabius GS MRI Anesthesia Machine
  FDA Device · Class II · 2018-06-27 · Draeger Medical
  Reason: 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. Potenti…
• Apollo Anesthesia Machine
  FDA Device · Class II · 2018-06-27 · Draeger Medical
  Reason: 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. Potenti…
• Perseus A500 Anesthesia Machine
  FDA Device · Class II · 2018-06-27 · Draeger Medical
  Reason: 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. Potenti…
• Fabius GS Tiro Anesthesia Machine
  FDA Device · Class II · 2018-06-27 · Draeger Medical
  Reason: 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. Potenti…
• Carina Ventilator, ventilator
  FDA Device · Class II · 2018-06-06 · Draeger Medical
  Reason: 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.
• Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating,…
  FDA Device · Class I · 2018-05-16 · Draeger Medical
  Reason: 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.
• Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, i…
  FDA Device · Class I · 2018-05-16 · Draeger Medical
  Reason: 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.
• Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, in…
  FDA Device · Class I · 2018-05-16 · Draeger Medical
  Reason: 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.
• Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operat…
  FDA Device · Class I · 2018-05-16 · Draeger Medical
  Reason: 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.
• Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing…
  FDA Device · Class I · 2016-08-10 · Draeger Medical
  Reason: Isolated episodes of leakage at the check valve were found
• Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non steri…
  FDA Device · Class II · 2016-08-03 · Draeger Medical
  Reason: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
• Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles
  FDA Device · Class II · 2016-06-01 · Draeger Medical
  Reason: 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…
• Evita Infinity V500 Ventilator
  FDA Device · Class I · 2016-03-02 · Draeger Medical
  Reason: 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 versio…
• Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831
  FDA Device · Class I · 2016-02-10 · Draeger Medical
  Reason: 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.
• Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080
  FDA Device · Class I · 2016-02-10 · Draeger Medical
  Reason: 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.
• Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator
  FDA Device · Class I · 2015-12-30 · Draeger Medical
  Reason: 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…
• Perseus A500 Anesthesia Workstation, MK06000
  FDA Device · Class I · 2015-12-23 · Draeger Medical
  Reason: 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 worksta…
• PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
  FDA Device · Class I · 2015-08-26 · Draeger Medical
  Reason: The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
• Fabius MRI Anesthesia Machine
  FDA Device · Class II · 2015-08-05 · Draeger Medical
  Reason: 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.
• Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets
  FDA Device · Class II · 2014-04-16 · Draeger Medical
  Reason: 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…
• Draeger Movita 603x/DVE 803x Ceiling Supply Unit
  FDA Device · Class II · 2013-11-20 · Draeger Medical
  Reason: 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).
• Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients…
  FDA Device · Class I · 2013-10-16 · Draeger Medical
  Reason: 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…
• Draeger Infinity Acute Care System (IACS) Monitoring Solution
  FDA Device · Class II · 2013-03-20 · Draeger Medical
  Reason: 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…