Company: Impedimed Limited Date of Enforcement Report: 10/24/2023 Class II PRODUCT SOZO Bilateral Arm L-Dex Software Recall Number: Z-0155-2024 REASON: 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...Read More
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