BEUDAMED
    FDA Recall Terminated

    Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).

    Recall: Z-0281-2012 · Initiated October 31, 2011

    Recall

    Recall Number
    Z-0281-2012
    Event Number
    60269
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 31, 2011
    Posted
    November 23, 2011
    Terminated
    July 1, 2013
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).

    Reason

    Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.

    Action

    Firm initiated their recall of this device on October 25, 2011 by sending an "Urgent Medical Device Recall" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.

    Distribution

    Worldwide distribution- USA including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WI and WV and International distribution including the countries of Algeria, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brasilien, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Deutschland, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Finland, France, Frankreich, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indien, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Jordanien, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Madagascar, Malaysia, Malta, Mauritius, Mayotte, Mexico, Moldavia, Moldova, Morocco, Netherlands, Norway, Norway, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Rumania, Russian Fed., Saudi Arabia, Serbia, Seychelles, Singapore, Slovenia, Slowenien, South Africa, South Korea, Spain, Sri Lanka, S¿dafrika, Sweden, Switzerland, Syria, Taiwan, Thailand, Tschechische Republic, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and White Russia.

    Quantity

    14,894