112 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Trilogy Evo Universal, Product number DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 26, 2021
Puritan Bennett 980 Series Ventilator
FDA Recall
Open, Classified
·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022
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
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·May 29, 2024
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
Servo-n Ventilator System. Model Number: 6694800.
FDA Recall
Open, Classified
·Maquet Critical Care AB Rontgenvagen·Product code CBK·May 30, 2025
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code CBK·January 23, 2023
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
Ventilator HAMILTON-C6, PN: 160021
FDA Recall
Open, Classified
·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·May 15, 2024
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
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·February 3, 2025
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·May 10, 2021
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·June 14, 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
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code CBK·July 20, 2022
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