Impedimed Limited recalls SOZO Bilateral Arm L-Dex Software

Recall date

August 17, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0155-2024

FDA classification

Class II

Brand / firm

Impedimed Limited

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SOZO Bilateral Arm L-Dex Software