Skip to content
Recall Observatory FDA recall evidence

Device product

SOZO Bilateral Arm L-Dex Software

Z-0155-2024

August 17, 2023

Class II

Product summary

Firm
Impedimed Limited
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

    reason.no_named_rule · v1.0.0

    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.