PlainRecordsSOZO 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…
- Status
- Ongoing
- 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.
- Enforcement report date
- Nov. 1, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Impedimed Limited
- 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.
- 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.
- Quantity
- 354
- Codes and lots
- UDI-DI: B277SFT0250. Software v4.1 and v5.0
- Recall started
- Aug. 17, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- Root cause (FDA)
- Device Design
- What the company told customers
- 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 impedimed156@impedimed.com
- Recall number
- Z-0155-2024
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”SOZO Bilateral Arm L-Dex Software, FDA enforcement report, 2023-11-01. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Monitor, Extracellular Fluid, Lymphedema, Extremity
Distributed in (FDA's record): Alaska Arizona Arkansas California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Nebraska New Jersey New Mexico New York North Carolina North Dakota Ohio Oregon Pennsylvania Rhode Island South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wisconsin Wyoming and nationwide
This recall among the others
- FDA's enforcement report came 76 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0155-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0155-2024, Nov. 1, 2023. "SOZO Bilateral Arm L-Dex Software." PlainRecords, https://plainrecords.com/recall/device/z-0155-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections