348 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·January 31, 2007
Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
FDA Recall
Terminated
·MAQUET Inc.·Product code CBK·November 17, 2009
Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
FDA Recall
Terminated
·MAQUET Inc.·Product code CBK·May 23, 2006
Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
FDA Recall
Terminated
·MAQUET Inc.·Product code CBK·May 23, 2006
RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·October 15, 2007
Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·October 15, 2007
Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·December 15, 2008
Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
FDA Recall
Terminated
·Hamilton Medical Inc·Product code CBK·May 24, 2006
Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,
FDA Recall
Terminated
·Hamilton Medical Inc·Product code CBK·May 24, 2006
Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·June 1, 2001
Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBK·May 20, 2004
Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·January 25, 2008
SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
FDA Recall
Terminated
·MAQUET Inc.·Product code CBK·July 8, 2008
Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·February 22, 2008
Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
FDA Recall
Terminated
·Maquet Inc.·Product code CBK·December 22, 2011
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·January 25, 2013
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
FDA Recall
Terminated
·GE Healthcare·Product code CBK·January 27, 2015
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Terminated
·Philips Respironics·Product code CBK·January 18, 2016
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·October 29, 2014
Trilogy Evo Universal, Product number DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 26, 2021