Medimaps Group: Medical Device Recall in 2016 - (Recall #: Z-0369-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 16, 2016

Recall Number: Z-0369-2017

Event ID: 75510

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.

Status: Terminated

Product Quantity: 15 units in US

Code Information:

Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440

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.

Voluntary or Mandated:

Voluntary: Firm initiated