FDAFebruary 3, 2025device
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
What to do
FDA enforcement status: Ongoing
Brands named
medimaps
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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