Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number:… — Class II medical device recall Z-1250-2025
Ongoing recall by Medimaps Group, reported 2025-03-12, distributed in AL, AZ, CA, CO, DE, FL, IL, LA…. Potential variability in calculations from fast array scans compared to array scans when operating on Hologic
| Recall number | Z-1250-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medimaps Group, Plan-les-Ouates, Switzerland |
| Recall initiated | 2025-02-03 |
| Classified | 2025-02-28 |
| Reported by FDA | 2025-03-12 |
| Distributed | AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, PR, SC, TX, UT, WA |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CL, CO, CR, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HN, HU, IE, IL, IN, IT, JP, KR, LB, MA, MX, MY, NL, NO, NP, NZ, PE, PH, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UY, ZA |
Product
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No
Reason for recall
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
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-1250-2025. 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.