Philips Respironics, Inc.

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th

Philips Respironics, Inc.

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Philips Respironics, Inc.

DreamStation Auto. Non-Continuous Ventilator.

Philips Respironics, Inc.

DreamStation Auto CPAP. Non-Continuous Ventilator.

Philips Respironics, Inc.

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa

Philips Respironics, Inc.

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin

Philips Respironics, Inc.

BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more

Philips Respironics, Inc.

Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat

Philips Respironics, Inc.

Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200

Philips Respironics, Inc.

Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat

Philips Respironics, Inc.

Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa

Philips Respironics, Inc.

LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult

Philips Respironics, Inc.

Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100

Philips Respironics, Inc.

Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110

Philips Respironics, Inc.

Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2

Philips Respironics, Inc.

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

Philips Respironics, Inc.

Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E

Philips Respironics, Inc.

BiPAP V30 Auto Ventilator, Part Number 1111178

Philips Respironics, Inc.

BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111

Philips Respironics, Inc.

OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111

Philips Respironics, Inc.

BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11

Philips Respironics, Inc.

Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B

Philips Respironics, Inc.

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US)

Philips Respironics, Inc.

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Philips Respironics, Inc.

Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,

Philips Respironics, Inc.

Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110

Philips Respironics, Inc.

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Philips Respironics, Inc.

Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, F

Philips Respironics, Inc.

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U

Philips Respironics, Inc.

Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR

Philips Respironics, Inc.

Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

Philips Respironics, Inc.

Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15

Philips Respironics, Inc.

Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10

Philips Respironics, Inc.

Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800,

Philips Respironics, Inc.

Philips Garbin Ventilator, Model Number 1058180B

Philips Respironics, Inc.

Wisp and Wisp Youth Nasal Mask

Philips Respironics, Inc.

DreamWisp Nasal Mask with Over the Nose Cushion

Philips Respironics, Inc.

Philips Respironics Amara View Minimal Contact Full-Face Mask

Philips Respironics, Inc.

Therapy Mask 3100 NC/SP

Philips Respironics, Inc.

Philips Respironics DreamWear Full Face Mask

Philips Respironics, Inc.

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro

Philips Respironics, Inc.

Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s

Philips Respironics, Inc.

Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstru

Philips Respironics, Inc.

Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient

Philips Respironics, Inc.

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro

Philips Respironics, Inc.

Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne

Philips Respironics, Inc.

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in ho

Philips Respironics, Inc.

Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous

Philips Respironics, Inc.

Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides

Philips Respironics, Inc.

Trilogy Evo Universal, Product number DS2000X11B

Philips Respironics, Inc.

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA21

Philips Respironics, Inc.

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Philips Respironics, Inc.

Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X

Philips Respironics, Inc.

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

Philips Respironics, Inc.

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

Philips Respironics, Inc.

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbe

Philips Respironics, Inc.

SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators

Philips Respironics, Inc.

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Suppo

Philips Respironics, Inc.

DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Contin

Philips Respironics, Inc.