Company: Impedimed Limited
Date of Enforcement Report: 10/24/2023
Class II
PRODUCT
SOZO Bilateral Arm L-Dex Software
Recall Number:
Z-0155-2024
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.
RECALLING FIRM/MANUFACTURER:
Impedimed Limited
VOLUME OF PRODUCT IN COMMERCE:
354
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.
