BEUDAMED
    FDA Recall Terminated

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    Recall: Z-1640-2014 · Initiated April 9, 2014

    Recall

    Recall Number
    Z-1640-2014
    Event Number
    67620
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KOI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 9, 2014
    Posted
    May 21, 2014
    Terminated
    September 28, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    Reason

    When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual a

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter (Ref 36099) dated April 9, 2014 to affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information (contact Technical Support at 1-800-558-7044 or your local Service Representative). UPDATE: On May 11, 2015 a second GE Healthcare letter FMI 36099-2 was sent to OUS consignees. The updated report was for additional affected modules due to FRU installation.

    Distribution

    US Nationwide Distribution in the states of: AR, CA, CO,DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MI, MN, MO, NC, NV, NY, OH, OK, TN, TX, UT, WA, WI, WY. OUS: ARGENTINA. AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGRY, INDIA, IRA, ISRAEL, ITALY, JAPAN, KAZAKTSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PANAMA, POLAND, QATAR, ROMANIA, RUSSIAN, F¿D¿RATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, TAIWAN, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.

    Quantity

    1,794 (471 units US, 1,323 units OUS)