BEUDAMED
    FDA Enforcement Class II Terminated

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

    Recall: Z-0601-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0601-2020
    Event ID
    84132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2019
    Initiation Date
    October 16, 2019
    Classification Date
    December 5, 2019
    Termination Date
    June 30, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

    Reason

    Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.

    Code Info

    Serial numbers: 2015120001-2015120030 2016030001-2016030030 2016040001-2016040018 2016050001-2016050030 2016060001-2016060020 2016070001-2016070040 2016080001-2016080006 2016090001-2016090016 2016110001-2016110008 2016120001-2016120006 2017010001-2017010008 2017020001-2017020009 2017030001-2017030011 2017040001-2017040008 2017060001-2017060015 2017080002 2017080006 2017080010

    Distribution

    US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania.

    Quantity

    110