BEUDAMED
    FDA Recall 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 · Initiated March 18, 2020

    Recall

    Recall Number
    Z-1813-2020
    Event Number
    85297
    Firm
    WELCH ALLYN, INC/MORTARA
    FEI Number
    2183461
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 18, 2020
    Posted
    April 29, 2020
    Terminated
    February 9, 2026
    Address
    7865 N 86th St, Milwaukee, WI, 53224-3431

    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.

    Action

    Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed.

    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