42 results
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Sources: EU EUDAMED, US FDA
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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
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNS·April 6, 2021
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNS·April 6, 2021
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code CBK·November 19, 2019
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021