Draeger Medical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0008-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: August 14, 2013

Date Posted: October 16, 2013

Recall Number: Z-0008-2014

Event ID: 66025

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1127 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated