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Draeger Medical, Inc. recalls Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia an
Recalled October 16, 2013 · FDA recall Z-0008-2014 · Draeger Medical
Hazard
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. · FDA Class I
Units
1127 units
Sold at
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia Turkmenistan.
Description
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.
Product
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.
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →