Impedimed Limited recalls SOZO Bilateral Arm L-Dex Software
Recalled Product
SOZO Bilateral Arm L-Dex Software
Hazard / Issue
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.
Issued by
FDA
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