Device product
SOZO Bilateral Arm L-Dex Software
Z-0155-2024
Product summary
- Event
- Event 92943
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 354
- Official record key
device-enforcement:Z-0155-2024
Official wording
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.
Code information: UDI-DI: B277SFT0250. Software v4.1 and v5.0
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.