Reported Nov 1, 2023 · Ongoing
SOZO Bilateral Arm L-Dex Software
Impedimed Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Impedimed Limited · Building · Pinkenba, N/A · N/A
Is this the product you have?
- SOZO Bilateral Arm L-Dex Software
- Lot codes and dates
- UDI-DIB277SFT0250. Software v4.1 and v5.0
- Amount recalled
- 354
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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