Impedimed recalls SOZO Bilateral Arm L-Dex Software v4.1 and v5.0 due to potential under-recognition of early lymphedema. Affected users should contact for guidance.
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.
Impedimed is recalling its SOZO Bilateral Arm L-Dex Software versions 4.1 and 5.0 because it may not detect early lymphedema as well as the single-arm version. This could lead to delayed treatment and more aggressive interventions.
The software may not detect early signs of lymphedema in both arms as effectively as the single-arm version. This could cause delays in treatment and require more aggressive interventions later.
People using the SOZO Bilateral Arm L-Dex Software for lymphedema assessment, particularly those with bilateral arm conditions. Those with existing lymphedema are at higher risk.
Check for software versions 4.1 or 5.0 labeled with UDI-DI: B277SFT0250. The product is used for lymphedema assessment in both arms.
Reach out to Impedimed for guidance on next steps.
The recall indicates a potential risk of under-recognition of early lymphedema, but it is not immediately dangerous.
Software versions 4.1 and 5.0 with UDI-DI: B277SFT0250.
If you use the software for lymphedema assessment in both arms, you may need to monitor for early signs of lymphedema more closely.
We’ve drafted a message you can send Impedimed to request your refund or repair — edit it as you like.
Subject: Recall Z-0155-2024 — Impedimed Impedimed Hello, I own a Impedimed that is covered by recall Z-0155-2024 from Impedimed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
