SIEMENS Biograph Horizon 3R Mobile — Class II medical device recall Z-1134-2023
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2023-02-22, distributed nationwide. This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its sca
| Recall number | Z-1134-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2023-01-16 |
| Classified | 2023-02-13 |
| Reported by FDA | 2023-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, JP |
| Quantity | 1 units |
| Serial numbers | 94792 |
Product
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Reason for recall
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
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-1134-2023. 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.