BEUDAMED
    193 results · 25ms · Sources: EU EUDAMED, US FDA

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    Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMZ·January 31, 2008

    Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMZ·January 31, 2008

    Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, Inc., Telford, PA 18969

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMZ·January 31, 2008

    Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·July 29, 2011

    Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·July 29, 2011

    Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010

    Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010

    Delta/Delta XL Monitors with Omega S Package

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

    Drager Surgical Lights Sola 500 and Sola 700.

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

    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

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·July 13, 2015

    Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·March 28, 2017

    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·March 28, 2017

    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·December 1, 2015

    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·March 28, 2017

    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·February 4, 2016

    VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code OFP·December 21, 2018

    VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code OFP·December 21, 2018

    ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code OFP·December 21, 2018