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U.S. Department of Health and Human Services

Class 2 Device Recall TBS iNsight Version v.3.0.1

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  Class 2 Device Recall TBS iNsight Version v.3.0.1 see related information
Date Initiated by Firm October 03, 2016
Date Posted November 05, 2016
Recall Status1 Terminated 3 on June 07, 2017
Recall Number Z-0369-2017
Recall Event ID 75510
510(K)Number K152299  
Product Classification Densitometer, bone - Product Code KGI
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.
Code Information Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440
Recalling Firm/
Manufacturer		 Medimaps Group
Fongit
Chemin des Aulx 18
Plan-les-Ouates Switzerland
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 15 units in US
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGI and Original Applicant = MEDIMAPS GROUP SA
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