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DRAEGER MEDICAL INC

FABIUS TIRO · Anesthesiology

510(k): 4 Recall: 4 UDI: 0 MAUDE: 0 Class.: 59

510(k) Clearances (4)

FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM

2004-10-08

Substantially Equivalent

FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM

2004-08-31

Substantially Equivalent

MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM

2004-07-08

Substantially Equivalent

FABIUS TIRO ANESTHESIA SYSTEM

2003-07-15

Substantially Equivalent

Recalls (4)

Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are 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 ser

2018-03-01

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are 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 s

2018-03-01

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

2013-08-14

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.

2004-09-15

rotating knob of the rotary style APL valve can become separated from the assembly.

FDA Classification (59)

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Anesthesiology

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

Anesthesia Conduction Kit

Anesthesiology

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Anesthesiology

High Flow/High Velocity Humidified Oxygen Delivery Device

Anesthesiology

Monitor, Carbon-Dioxide, Cutaneous

Anesthesiology

Plethysmograph, Pressure

Anesthesiology

Caudal Anesthesia Kit

Anesthesiology

Regulator, Pressure, Gas Cylinder

Anesthesiology

Bag, Reservoir

Anesthesiology

Brush, Cleaning, Tracheal Tube

Anesthesiology

Analyzer, Nitrogen Dioxide

Anesthesiology

Algesimeter, Powered

Anesthesiology

Ventilatory Effort Recorder

Anesthesiology

Adjunctive Pain Measurement Device For Anesthesiology

Anesthesiology

Rhinoanemometer (Measurement Of Nasal Decongestion)

Anesthesiology

Cabinet, Table And Tray, Anesthesia

Anesthesiology

Spreader, Cuff

Anesthesiology

Stethoscope, Esophageal

Anesthesiology

Oral Airway Assist

Anesthesiology

Spirometer, Diagnostic

Anesthesiology

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

Sparse Sample Pk Profile And Dosing Software

Anesthesiology

Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

Airway, Nasopharyngeal

Anesthesiology

Device Indicating An Exhalation Event

Anesthesiology

Spacer, Direct Patient Interface

Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

Apparatus, Gas-Scavenging

Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

Circulator, Breathing-Circuit

Anesthesiology

Percussor, Powered-Electric

Anesthesiology

Laryngoscope, Rigid

Anesthesiology

Blood Specimen Collection Kit (Excludes Hiv Testing)

Anesthesiology

Catheter, Nasal, Oxygen

Anesthesiology

Stimulator, Nerve, Ac-Powered

Anesthesiology

Valve, Switching (Ploss)

Anesthesiology

Stool, Anesthesia

Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

Anesthesiology

Stimulator, Nerve, Battery-Powered

Anesthesiology

Mask, Oxygen, Non-Rebreathing

Anesthesiology

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology

Cardiopulmonary Resuscitation Aid Kit

Anesthesiology

Catheters, Suction, Tracheobronchial

Anesthesiology

Spinal Anesthesia Kit

Anesthesiology

Analyzer, Nitrogen Dioxide, Exempt

Anesthesiology

Calibrator, Pressure, Gas

Anesthesiology

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

Protector, Dental

Anesthesiology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Anesthesiology

Valve, Non-Rebreathing

Anesthesiology

Monitor, Breathing Frequency

Anesthesiology

Hood, Oxygen, Infant

Anesthesiology

Medevac Use Oxygen Generator

Anesthesiology

Support, Patient Position

Anesthesiology

Strap, Head, Gas Mask

Anesthesiology

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology