BEUDAMED
    FDA Enforcement Class II Terminated

    T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.

    Recall: Z-1813-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1813-2020
    Event ID
    85297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WELCH ALLYN, INC/MORTARA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 18, 2020
    Classification Date
    April 29, 2020
    Termination Date
    February 9, 2026
    Address
    7865 N 86th St, N/A, Milwaukee, WI, 53224-3431, United States

    Description

    T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.

    Reason

    Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

    Code Info

    Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.

    Distribution

    US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.

    Quantity

    78,521 units total