Impedimed Limited: Medical Device Recall in 2023 - (Recall #: Z-0155-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

SOZO Bilateral Arm L-Dex Software

Product Classification:

Class II

Date Initiated: August 17, 2023

Date Posted: November 1, 2023

Recall Number: Z-0155-2024

Event ID: 92943

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.

Status: Ongoing

Product Quantity: 354

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.

Voluntary or Mandated:

Voluntary: Firm initiated