Impedimed Limited is recalling 354 units of its SOZO Bilateral Arm L-Dex Software, specifically versions 4.1 and 5.0. The software used for bilateral arm assessments does not have the same level of sensitivity as the unilateral (one-arm) version when trying to detect early signs of lymphedema. This software defect could cause doctors to miss early warning signs of the condition, leading to delayed medical intervention and potentially requiring more aggressive treatment later on. These software versions were distributed across 40 U.S. states and the District of Columbia.
The software may fail to accurately flag early lymphedema symptoms during bilateral assessments. This under-recognition can delay critical early-stage treatment, allowing the condition to progress to a point where more invasive or aggressive medical procedures are necessary.
Manufacturer Notification and Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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