Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: Recalled by Medimaps Group Due to Potential variability in calculations from fast array scans...
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
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 bone microarchitecture and bone health management Component: No
Quantity: 2036 units (724 US, 1312 OUS)
Why Was This Recalled?
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Where Was This Sold?
This product was distributed to 23 states: AL, AZ, CA, CO, DE, FL, IL, LA, MD, MA, MI, MN, MS, MO, NM, NY, NC, OH, PA, SC, TX, UT, WA
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