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 | Terminated |
| Reason | There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. |
| Product | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems |
| Quantity | 7 devices |
| Distribution | Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK. |
| Initiated | 2022-03-11 |
| Classified | 2022-04-07 |
| Terminated | 2023-04-14 |
| Recall number | Z-0893-2022 |
| 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-0893-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89790/
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