Z-0155-2024 Class II Ongoing
FDA device recall Z-0155-2024 was initiated by Impedimed Limited on August 17, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 354.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 354
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.
Distribution Pattern
US Nationwide distribution in the states of IA, CA, IL, AK, NY, FL, KS, WI, MI, NC, GA, SD, KY, TX, MA, LA, AZ, RI, AR, CO, WY, OH, IN, MO, NJ, MD, CT, WA, PA, UT, VA, NM, ME, MN, DC, TN, NE, OR, ND, WV.
Code Information
UDI-DI: B277SFT0250. Software v4.1 and v5.0