91 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 2, 2026
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·May 1, 2023
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·December 22, 2021
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 2, 2026
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 16, 2024
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·November 27, 2023
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 2, 2026
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 1, 2023
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 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
CareFusion Alaris Pump Module, Model 8100
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 4, 2020
CareFusion Alaris Syringe Module, Model 8110
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 4, 2020
Aeris EVO. Model Number: VT2110X24B. 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
CareFusion Alaris PCA Module, Model 8120
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 4, 2020
Garbin Evo. Model Number: LD2110X23B. 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
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 4, 2020
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. 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 EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 1, 2023
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HRS·November 1, 2021