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Medimaps Group recalls TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densit
Recalled November 16, 2016 · FDA recall Z-0369-2017 · Medimaps Group
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. · FDA Class II
Units
15 units in US
Sold at
Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
Description
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.
Product
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.
Manufacturer(s)
Medimaps Group
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →