Recall Z-0369-2017 ยท KGI Densitometer, Bone
Medimaps Group
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.
| Date | Nov 5, 2016 (initiated Oct 3, 2016) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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 Republ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152299 | TBS iNsight Medimaps Group SA, Apr 29, 2016 |