Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a Recalled by Medimaps Group Due to The FRAX adjusted for TBS values are not...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medimaps Group directly.
Affected Products
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.
Quantity: 15 units in US
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medimaps Group
Medimaps Group has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report