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.
FDA Recall Z-0369-2017 · Posted 2016-11-05
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Recalling FirmMedimaps Group
Recall StatusTerminated
Product CodeKGI
Date Initiated2016-10-03
Date Terminated2017-06-07
Product Quantity15 units in US
Reason for Recall
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.
Firm Action
Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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