TBS iNsight Version v — Class II medical device recall Z-0369-2017
Terminated recall by Medimaps Group, reported 2016-11-16, distributed nationwide. The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS h
| Recall number | Z-0369-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medimaps Group, Plan-les-Ouates, Switzerland |
| Recall initiated | 2016-10-03 |
| Classified | 2016-11-05 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DK, ES, FR, GB, HK, HR, IQ, IR, IT, KR, LB, LT, MX, NL, NZ, RO, RS, SA, SE, TH, UA, ZA |
| Quantity | 15 units |
| Serial numbers | 100112, 100202, 14295, 200042, 201120, 210020, 210440, 300409, 500581, 70103, 70174, 70580, 80936, 83769, 84584 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0369-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.