| Class 2 Device Recall TBS iNsight Version v.3.0.1 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KGI
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