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.

Recall Insight

This FDA Devices action (record #Z-0369-2017) was formally reported on November 16, 2016, with the manufacturer initiating the action on October 3, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Medimaps Group is listed as the recalling firm, operating out of Plan-les-Ouates. Federal records indicate 15 units in US units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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 Afric…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.