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.

Reason: 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.

Code information: Part Nos. 8607000 (GS Permium) 8606000 (Fabius OS and Fabius Tiro) 8608400 (Fabius Tiro D-M)ASEC-0055 with lot numbers: ASEC-0186, ASED-0006, ASED-0074, ASED-0291, ASEC-0056, ASEC-0205, ASED-0007, SED-0075 ASED-0292, ASEC-0061, ASEC-0206, ASED-0020, ASED-0079, ASED-0293, ASEC-0062, ASEC-0207, ASED-0021, ASED-0139, ASED-0294, ASEC-0070, ASEC-0208, ASED-0023, ASED-0160, ASED-0295, ASEC-0071, ASEC-0209, ASED-0024, ASED-0161, ASED-0296, ASEC-0112, ASEC-0210, ASED-0025, ASED-0162, ASEE-0021, ASEC-0124, SEC-0211, ASED-0031, ASED-0163, ASEE-0022, ASEC-0125, ASEC-0212, ASED-0032, ASED-0164, ASEE-0023, ASEC-0126, ASEC-0213, ASED-0033, ASED-0165, ASEE-0041, ASEC-0169, ASEC-0214, ASED-0034, ASED-0166, ASEE-0042, ASEC-0170, ASEC-0236, ASED-0035, ASED-0167, ASEE-0058, ASEC-0171, ASEC-0248, ASED-0036, ASED-0168, ASEE-0060, ASEC-0172, ASEC-0249, ASED-0037, ASED-0169, ASEE-0061, ASEC-0173, ASEC-0250, ASED-0038, ASED-0203, ASEE-0065, ASEC-0174, ASED-0001, ASED-0044, ASED-0253, ASEE-0066, ASEC-0175, ASED-0002, ASED-0045, ASED-0286, ASEE-0083, ASEC-0176, ASED-0003, ASED-0046, ASED-0287, ASEE-0103, ASEC-0184, ASED-0004, ASED-0047, ASED-0288, ASEE-0136, ASEC-0185, ASED-0005, ASED-0051, ASED-0290, ASEC-0054, ASEC-0194, ASED-0247, ASED-0263, ASEE-0072, ASEC-0167, ASEC-0195, ASED-0248, ASED-0264, ASEE-0089, ASEC-0178, ASEC-0196, ASED-0254, ASED-0265, ASEE-0090, ASEC-0179, ASEC-0197, ASED-0255, ASED-0266, ASEE-0131, ASEC-0180, ASEC-0227, ASED-0256, ASED-0282, ASEE-0132, ASEC-0181, ASEC-0228, ASED-0257, ASEE-0003, ASEE-0133, ASEC-0182, ASED-0040, ASED-0260, ASEE-0017, ASEE-0134, ASEC-0183, ASED-0086, ASED-0261, ASEE-0054, ASEC-0193, ASED-0245, ASED-0262, ASEE-0071, ASED-0141, ASED-0143, ASED-0145, ASED-0147, ASED-0149, ASED-0142, ASED-0144, ASED-0146, ASED-0148, ASEB-0219

Distribution pattern: 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.