Z-0369-2017 Class II Terminated
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