BEUDAMED
    FDA Recall Open, Classified

    SOZO Bilateral Arm L-Dex Software

    Recall: Z-0155-2024 · Initiated August 17, 2023

    Recall

    Recall Number
    Z-0155-2024
    Event Number
    92943
    FEI Number
    3004782476
    Product Code
    OBH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 17, 2023
    Posted
    October 24, 2023
    Address
    Impedimed Limited Building U 1 50 Parker Ct Pinkenba 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.

    Action

    On 8/17/23, correction notices were emailed to customers. Customers were asked to take the following actions: We recommend that you confirm the risk profile of your bilateral arm patients in MySOZO and take the following actions: - For patients at unilateral risk for lymphedema (over 90% of breast cancer patients), confirm that the unilateral arm L-Dex assessment is selected in the patient profile and continue to screen for early signs of lymphedema. - For patients at bilateral risk for lymphedema (3-10% of breast cancer patients), guidelines suggest routine screening using clinical exam and symptom assessment. - Complete and return the response form via link: https://forms.office.com/r/kafiuDbw21 In September, the firm will be issuing a SOZO software update to make unilateral L-Dex the sole assessment option for arms. L-Dex assessments for legs will not be impacted. This correction letter should be shared with anyone within your organization who needs to be aware of the correction or with any organization where the device may have been transferred. If you have questions or need to report quality issues, call 1/877/247-0111, Option 4 (Mon-Fri, 8:00 am - 8:00 om ET) or email [email protected]

    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