Home / Recalls / Medical Devices
Impedimed Limited recalls SOZO Bilateral Arm L-Dex Software
Recalled November 1, 2023 · FDA recall Z-0155-2024 · Impedimed
Hazard
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. · FDA Class II
Units
354
Sold at
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.
Description
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.
Product
SOZO Bilateral Arm L-Dex Software
Manufacturer(s)
Impedimed Limited
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →