Biograph Horizon — Class II medical device recall Z-1930-2018
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2018-05-30. Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating
| Recall number | Z-1930-2018 |
|---|---|
| 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 | 2018-02-21 |
| Classified | 2018-05-24 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2018-10-12 |
| Countries outside the US | FI, FR, IE, IR, IT, JP, NL |
| Quantity | 14 units |
| Reason classes | software |
Product
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Reason for recall
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
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-1930-2018. 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.