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Z-0369-2017 Class II Terminated

Recalled by Medimaps Group — Plan-les-Ouates

FDA device recall Z-0369-2017 was initiated by Medimaps Group on October 3, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 7, 2017). Affected quantity: 15 units in US.

Recall Details

Product Type: Devices
Report Date: November 16, 2016
Initiation Date: October 3, 2016
Termination Date: June 7, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15 units in US

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.

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.

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.

Code Information

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