Recall Z-0155-2024— Impedimed Limited
Class II · Ongoing
Class II FDA medical device recall by Impedimed Limited, initiated 2023-08-17. It names one FDA 510(k) clearance: K180126. Product: SOZO Bilateral Arm L-Dex Software. 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 result in delay in early intervention, and more aggressive intervention..
- Recalling firm
- Impedimed Limited
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-17
- Firm location
- Pinkenba, N/A, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SOZO Bilateral Arm L-Dex Software
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.