BIOGRAPH 64 — Class II medical device recall Z-2013-2016
Terminated recall by Siemens Medical Solutions USA Inc., reported 2016-06-29, distributed nationwide. Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a no
| Recall number | Z-2013-2016 |
|---|---|
| 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 | 2016-04-22 |
| Classified | 2016-06-21 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Serial numbers | 1001, 1002, 1003, 1004, 1007, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1022 |
Product
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Reason for recall
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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-2013-2016. 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.