Biograph 16 TruePoint TrueV — Class II medical device recall Z-1425-2017
Terminated recall by Siemens Medical Solutions USA Inc., reported 2017-03-15, distributed nationwide. The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
| Recall number | Z-1425-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA Inc., Knoxville, TN, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2017-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, GB, IT |
| Quantity | 4 units |
Product
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Reason for recall
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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-1425-2017. 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.