SOZO Bilateral Arm L-Dex Software inadequate lymphedema detection sensitivity
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves inadequate diagnostic sensitivity that could result in under-recognition of lymphedema and delayed treatment. As no illnesses or injuries have been reported and the potential harm is theoretical, the severity is rated as High per the rubric.
Plain-English summary
The FDA has recalled the SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0), manufactured by Impedimed Limited. The recall affects 354 units distributed nationwide across 43 states and Washington, DC.
The bilateral L-Dex assessment software has reduced sensitivity compared to the unilateral arm L-Dex assessment for detecting early lymphedema. This lower sensitivity could result in under-recognition of early lymphedema, which could lead to delayed early intervention and require more aggressive treatment later.
Healthcare facilities and providers using this software should contact Impedimed Limited for guidance regarding available remediation measures or software updates. For additional information about this recall, refer to the FDA's official recall notice.
The recalled product
- Product
- SOZO Bilateral Arm L-Dex Software
- Manufacturer
- Impedimed Limited
- Affected units
- 354
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: B277SFT0250. Software v4.1 and v5.0
Distribution
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