BEUDAMED
    74 results · 49ms · Sources: EU EUDAMED, US FDA

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    Trilogy Evo Universal, Product number DS2000X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 26, 2021

    Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·December 7, 2022

    Philips Garbin Ventilator, Model Number 1058180B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·December 7, 2022

    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNT·March 26, 2024

    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·June 14, 2021

    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 1, 2023

    Trilogy Evo Universal Ventilator, Model No. DS2000X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 16, 2024

    BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNT·May 9, 2025

    Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·May 1, 2023

    Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024

    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024

    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code NOU·July 26, 2021

    DreamStation Auto BiPAP. Non-Continuous Ventilator.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·June 30, 2025

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

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·June 14, 2021

    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code NOU·July 26, 2021

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is 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. It is not intended to be used as a transport ventilator.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·June 12, 2018

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

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 19, 2024

    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024

    Philips Respironics DreamWear Full Face Mask

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·September 6, 2022

    Therapy Mask 3100 NC/SP

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·September 6, 2022