BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0008-2014 · Initiated August 14, 2013

    Recall

    Recall Number
    Z-0008-2014
    Event Number
    66025
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 14, 2013
    Posted
    October 10, 2013
    Terminated
    September 23, 2014
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    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.

    Action

    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).

    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.

    Quantity

    1127 units