48 results
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86ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·08592346004337·Zen-O™ Portable Oxygen Concentrator
GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·08592346805477·ZenO Lite Portable Oxygen Concentrator
Arya
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·05060456420017·Zen-O lite Portable Oxygen Concentrator rebrand...
GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·08592346904156·Zen-O™ Portable Oxygen Concentrator
GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·08592346679832·Zen-O™ Clarity Portable Oxygen Concentrator
GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·08592346658110·Zen-O Lite Portable Oxygen Concentrator
GCE
FDA UDI
GAS CONTROL EQUIPMENT LIMITED·05060456420000·Zen-O Lite Clarity Portable Oxygen Concentrator
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 30, 2013
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 23, 2022
HIGH FLOW INSUFFLATION UNIT
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code HIF·January 31, 2022
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·November 12, 2024
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·November 6, 2024
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·November 6, 2024
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 27, 2018
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·May 5, 2025
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 27, 2018
ATLAN A300
FDA Adverse Event
Malfunction
·DRÄGERWERK AG & CO. KGAA·Product code BSZ·May 7, 2025
SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC·Product code DTX·August 9, 2022
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·October 31, 2024
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 27, 2018