FDAOctober 3, 2016device
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.
What to do
FDA enforcement status: Terminated
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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