Company:Medimaps Group
Date of Enforcement Report 11/16/2016
Class lI:
PRODUCT
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 Number Z-0369-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Medimaps Group, Switzerland on 11/5/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15 units in US
DISTRIBUTION
Nationwide and Internationally
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