# FDA recall Z-0155-2024

> **Impedimed Limited** · Class II · device recall initiated 2023-08-17.

## 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

- **Recall number:** Z-0155-2024
- **Recalling firm:** Impedimed Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-17
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pinkenba, N/A, Australia

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0155-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0155-2024. Source: US FDA. Licensed CC0.

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