Reported Nov 16, 2016 · Terminated
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone…
Medimaps Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medimaps Group · Fongit · Plan-les-Ouates · N/A
Is this the product you have?
- TBS iNsight Version v.3.0.1
- Product UsageTBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management
- Lot codes and dates
Version v.3.0.1Serial # 14295300409705802000425005817010370174809361002022011208458483769100112210020210440
- Amount recalled
- 15 units in US
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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