FDAAugust 17, 2023device
SOZO Bilateral Arm L-Dex Software
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
impedimed
Recall history
No related federal recalls on record for this brand yet.
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