medical Class II Updated 2023-11-01

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: B277SFT0250. Software v4.1 and v5.0
View official government recall

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