Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems — Class II medical device recall Z-0893-2022
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2022-04-13. There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety
| Recall number | Z-0893-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2022-03-11 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-04-14 |
| Countries outside the US | DE, FR, GB, JP, SV, TW |
| Quantity | 7 devices |
| Model numbers | 10764803, 11007962 |
Product
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Reason for recall
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
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-0893-2022. 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.