102 results
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Sources: EU EUDAMED, US FDA
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Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
FDA Enforcement
Class I
·Terminated·Respironics, Inc.·August 1, 2012
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
DreamStation Auto CPAP. Non-Continuous Ventilator.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·August 20, 2025
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·August 20, 2025
DreamStation Auto. Non-Continuous Ventilator.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·August 20, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024