Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
| Product | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission |
| Quantity | 1 unit |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia. |
| Initiated | 2023-01-16 |
| Classified | 2023-02-13 |
| Recall number | Z-1134-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-1134-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91518/
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