SOZO Bilateral Arm L-Dex Software
Reported: November 1, 2023 Initiated: August 17, 2023 #Z-0155-2024
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.
Details
- Recalling Firm
- Impedimed Limited
- Units Affected
- 354
- Distribution
- 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.
- Location
- Pinkenba, N/A
Frequently Asked Questions
What product was recalled? ▼
SOZO Bilateral Arm L-Dex Software. Recalled by Impedimed Limited. Units affected: 354.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0155-2024.
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