BEUDAMED
    28 results · 21ms · Sources: EU EUDAMED, US FDA

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    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·May 31, 2016

    Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code CBK·August 19, 2010

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BTL·March 5, 2014

    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·June 22, 2015

    Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·December 22, 2015

    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·December 22, 2015

    Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·January 21, 2009

    Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·August 14, 2013

    Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·November 12, 2015

    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code CBK·February 7, 2014

    Drager Surgical Lights Sola 500 and Sola 700.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·August 26, 2009

    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMT·June 22, 2016

    Delta/Delta XL Monitors with Omega S Package

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·November 9, 2009

    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FQO·September 30, 2013

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·July 7, 2008

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·December 13, 2012

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 24, 2010

    Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·February 5, 2008

    Drager PT 4000 Phototherapy System

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code LBI·July 2, 2012