FDA Device recall Z-0369-2017
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…
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of 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… by Medimaps Group, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0369-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-03 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medimaps Group |
| Distribution | US |
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.
Identifiers
| code_info | Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0369-2017%22
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