Biograph Horizon — Class II medical device recall Z-1597-2018
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2018-05-09, distributed nationwide. Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed impr
| Recall number | Z-1597-2018 |
|---|---|
| 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 | 2018-01-26 |
| Classified | 2018-05-02 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-10-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR, IN, JP, NL |
| Quantity | 42 units |
| Reason classes | software |
Product
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Reason for recall
Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
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-1597-2018. 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.