Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0155-2024 — SOZO Bilateral Arm L-Dex Software

U.S. FDA — Device Enforcement · Australia · 2023-08-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0155-2024
Date of alert
2023-08-17
Country / jurisdiction
Australia
Risk level
Class II
Risk type
recall
Brand
Impedimed Limited
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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