21 results · 57ms · Sources: EU EUDAMED, US FDA

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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

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

Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PL VC I user interface has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of patient settings and for the display of alarm conditions. PL VC I provides the following types of ventilatory support: 1) Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure (CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure Support (PS). Available in SIMV and SPONT.

FDA Recall
Terminated ·Respironics California Inc·Product code CBK·March 20, 2006

RESPIRONICS V60 VENTILATOR

FDA Recall
Terminated ·Respironics California Inc·Product code MNT·October 26, 2009

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 Recall
Terminated ·Respironics California Inc·Product code MNT·April 24, 2017

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 Recall
Terminated ·Respironics California Inc·Product code MNT·February 1, 2017

ESPRIT VENTILATOR, Model V1000

FDA Recall
Terminated ·Respironics California Inc·Product code CPK·June 8, 2001

Esprit Ventilator.

FDA Recall
Terminated ·Respironics California Inc·Product code CBK·July 14, 2003

The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: . Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT.

FDA Recall
Terminated ·Respironics California Inc·Product code CBK·November 18, 2005