Medimaps Group is recalling approximately 2,036 units of its TBS iNsight Bone Analysis software, specifically versions 3.0.0 through 3.1.2. The software, used on Hologic Horizon bone scanning machines, may produce inaccurate bone health calculations when performing fast array scans compared to standard scans. This discrepancy could lead to incorrect bone microarchitecture assessments, though no injuries or incidents have been reported.
The software calculations may be inconsistent, potentially providing medical professionals with inaccurate data about a patient's bone health. This could lead to a misdiagnosis or the creation of an inappropriate treatment plan for patients being evaluated for bone-related conditions.
Software is installed on Hologic Horizon bone densitometers for analysis of bone microarchitecture.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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