Nov

2016

TBS iNsight Version v.3.0.1 Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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TBS iNsight Version v.3.0.1 Cl II

Amy Sellers

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