FDA recall Z-0155-2024

Impedimed Limited · Class II · device

Product

SOZO Bilateral Arm L-Dex Software

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2023-08-17
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pinkenba, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2024