Recall Z-0155-2024 ยท OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Impedimed Limited
SOZO Bilateral Arm L-Dex Software
| Date | Oct 24, 2023 (initiated Aug 17, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On 8/17/23, correction notices were emailed to customers. Customers were asked to take the following actions: We recommend that you confirm the risk profile of your bilateral arm patients in MySOZO and take the following actions: - For patients at unilateral risk for lymphedema (over 90% of breast cancer patients), confirm that the unilateral arm L-Dex assessment is selected in the patient profile and continue to screen for early signs of lymphedema. - For patients at bilateral risk for lymphedema (3-10% of breast cancer patients), guidelines suggest routine screening using clinical exam and |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180126 | SOZO ImpediMed Limited, Apr 16, 2018 |