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.
This recall has been terminated (originally issued October 10, 2013).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- August 14, 2013
- Posted
- October 10, 2013
- Terminated
- September 23, 2014
- Recall Number
- Z-0008-2014
- Quantity
- 1127 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
The firm, Drager, sent an "Urgent Medical Device Recall" letter dated August 2013 to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that in the event of a failure, manual ventilation mode should be used and that Draeger reps would be contacting customers to schedule the replacement of the power supply. The customers were instructed to notify personnel accordingly. If you have any questions, contact Director, Quality at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DragerService Technical Support at 1-800-543-5047 (press 4 at the prompt).