Horizon X-Ray Bone Densitometer — Class II medical device recall Z-2373-2024
Ongoing recall by Hologic Inc, reported 2024-07-24, distributed nationwide. Non-conformance pertains to electromagnetic compatibility requirements according to the international technica
| Recall number | Z-2373-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic Inc, Newark, DE, United States |
| Recall initiated | 2024-06-13 |
| Classified | 2024-07-16 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CY, DE, DO, DZ, EE, ES, FR, GB, GR, HK, HR, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, MA, MT, MX, MY, NL, NP, NZ, PE, PH, PK, PL, PT, QA, RO, RS, SA, SG, SK, TH, TR, TW, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 15420045505384, 15420045505698, 15420045505827, 15420045505834, 15420045505865 |
| Serial numbers | 305588M, 305953M, 305954M, 305955M, 305956M, 305957M, 305958M, 305959M, 305960M, 305961M, 305962M, 305963M, 305964M, 305965M, 305966M, 305967M, 305968M, 305969M, 305970M, 305971M, 305972M, 305973M, 305974M, 305975M, 305976M and 475 more |
Product
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
Reason for recall
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
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-2373-2024. 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.