FDA Device recall Z-0155-2024
SOZO Bilateral Arm L-Dex Software
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of SOZO Bilateral Arm L-Dex Software by Impedimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0155-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-17 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Impedimed |
| Distribution | US |
Product
SOZO Bilateral Arm L-Dex Software
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.
Identifiers
| code_info | UDI-DI: B277SFT0250. Software v4.1 and v5.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0155-2024%22
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