BEUDAMED
    FDA Enforcement Class II Terminated

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    Recall: Z-1951-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1951-2012
    Event ID
    61529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 18, 2012
    Initiation Date
    June 15, 2012
    Classification Date
    July 6, 2012
    Termination Date
    August 7, 2012
    Address
    6797 Winchester Cir, Boulder, CO, 80301-3513, United States

    Description

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    Reason

    Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.

    Code Info

    RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.

    Distribution

    Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.

    Quantity

    48 boxes