Recall Z-0369-2017— Medimaps Group
Class II · Terminated
Class II FDA medical device recall by Medimaps Group, initiated 2016-10-03, terminated 2017-06-07. It names one FDA 510(k) clearance: K152299. 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.. 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
- Medimaps Group
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-03
- Terminated
- 2017-06-07
- Firm location
- Plan-les-Ouates, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.