BEUDAMED
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    Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·July 2, 2010

    Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·April 22, 2009

    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

    Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·January 25, 2008

    Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·January 25, 2008

    Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNS·September 22, 2008

    Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·June 4, 2013

    Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.

    FDA Enforcement
    Class I ·Terminated·Respironics California Inc·October 29, 2014

    Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.

    FDA Enforcement
    Class I ·Terminated·Respironics California Inc·May 24, 2017

    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

    FDA Enforcement
    Class II ·Terminated·Respironics California Inc·September 4, 2013

    Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

    FDA Enforcement
    Class I ·Terminated·Respironics California Inc·June 26, 2013

    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709

    FDA Enforcement
    Class II ·Terminated·Respironics California Inc·April 5, 2017

    V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

    FDA Enforcement
    Class I ·Terminated·Respironics California Inc·September 12, 2012

    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 Enforcement
    Class II ·Terminated·Respironics California Inc·December 3, 2014

    Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·June 1, 2001

    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

    Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·August 8, 2006

    V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·July 31, 2012

    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·October 29, 2007

    Esprit Ventilator

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·February 20, 2002