SOZO Bilateral Arm L-Dex Software — Class II medical device recall Z-0155-2024
Ongoing recall by Impedimed Limited, reported 2023-11-01, distributed nationwide. Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of
| Recall number | Z-0155-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impedimed Limited, Pinkenba, N/A, Australia |
| Recall initiated | 2023-08-17 |
| Classified | 2023-10-24 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 354 |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0155-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.