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U.S. Department of Health and Human Services

Class 2 Device Recall SOZO Software LDex Bilateral Arms, Software version 4.1 and 5.0

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  Class 2 Device Recall SOZO Software LDex Bilateral Arms, Software version 4.1 and 5.0 see related information
Date Initiated by Firm August 17, 2023
Date Posted October 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-0155-2024
Recall Event ID 92943
510(K)Number K180126  
Product Classification Monitor, extracellular fluid, lymphedema, extremity - Product Code OBH
Product SOZO Bilateral Arm L-Dex Software
Code Information UDI-DI: B277SFT0250. Software v4.1 and v5.0
Recalling Firm/
Manufacturer		 Impedimed Limited
Building
U 1 50 Parker Ct
Pinkenba Australia
For Additional Information Contact
61 7 34231777
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OBH and Original Applicant = ImpediMed Limited
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