Z-0155-2024Class II

SOZO Bilateral Arm L-Dex Software

Name: Z-0155-2024 SOZO Bilateral Arm L-Dex Software
Creator: Impedimed Limited
Published: 2023-08-17
License: https://open.fda.gov/license/

Impedimed, Inc. / initiated 2023-08-17 / Open, Classified / root cause: design

FDA source

Impedimed Limited began a recall of SOZO Bilateral Arm L-Dex Software on 2023-08-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0155-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-17
Posted: 2023-10-24
Recalling firm: Impedimed, Inc.
Product: SOZO Bilateral Arm L-Dex Software
Product code: OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
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.
Root cause tag: design
FDA 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 symptom assessment. - Complete and return the response form via link: https://forms.office.com/r/kafiuDbw21 In September, the firm will be issuing a SOZO software update to make unilateral L-Dex the sole assessment option for arms. L-Dex assessments for legs will not be impacted. This correction letter should be shared with anyone within your organization who needs to be aware of the correction or with any organization where the device may have been transferred. If you have questions or need to report quality issues, call 1/877/247-0111, Option 4 (Mon-Fri, 8:00 am - 8:00 om ET) or email [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: B277SFT0250. Software v4.1 and v5.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0155-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24

Product code OBH

K180126Class IISozoImpediMed Limited / cleared 2018-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)