BEUDAMED
    FDA Enforcement Class II Ongoing

    SOZO Bilateral Arm L-Dex Software

    Recall: Z-0155-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0155-2024
    Event ID
    92943
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Impedimed Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 1, 2023
    Initiation Date
    August 17, 2023
    Classification Date
    October 24, 2023
    Address
    Building, U 1 50 Parker Ct, Pinkenba, N/A, N/A, Australia

    Description

    SOZO Bilateral Arm L-Dex Software

    Reason

    Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.

    Code Info

    UDI-DI: B277SFT0250. Software v4.1 and v5.0

    Distribution

    US Nationwide distribution in the states of IA, CA, IL, AK, NY, FL, KS, WI, MI, NC, GA, SD, KY, TX, MA, LA, AZ, RI, AR, CO, WY, OH, IN, MO, NJ, MD, CT, WA, PA, UT, VA, NM, ME, MN, DC, TN, NE, OR, ND, WV.

    Quantity

    354