Medimaps Group

2 recalls •

• Categories: Diagnostic Equipment

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

Class I - Dangerous

Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.

Feb 3, 2025 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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.

Oct 3, 2016 Diagnostic Equipment Nationwide View Details →