FDA Medical Device Recalls (openFDA)
Impedimed Limited: SOZO Bilateral Arm L-Dex Software
- Recall number
- Z-0155-2024
- Recalling firm
- Impedimed Limited
- Product
- SOZO Bilateral Arm L-Dex Software
- Status
- Open, Classified
- Initiated
- 2023-08-17
- Posted
- 2023-10-24
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- UDI-DI: B277SFT0250. Software v4.1 and v5.0
- 510(k) numbers
- K180126
- PMA numbers
- not on file
- Product code
- OBH
- Firm FEI
- 3004782476
- Firm city
- Pinkenba
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28