Siemens Biograph Horizon PET/CT System — Class II medical device recall Z-0707-2019
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2019-01-16, distributed nationwide. Improper design or specifications.
| Recall number | Z-0707-2019 |
|---|---|
| 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 | 2018-11-30 |
| Classified | 2019-01-10 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BH, BR, CL, CN, CO, DE, ES, FR, GB, IE, IN, IR, IT, JP, LB, LK, MX, NL, NZ, PH, TR, TW, ZA |
| Quantity | 171 |
| Serial numbers | 94401, 94402, 94405, 94406, 94407, 94408, 94409, 94410, 94412, 94413, 94414, 94415, 94416, 94417, 94418, 94419, 94420, 94421, 94422, 94423, 94424, 94425, 94426, 94427, 94428 and 131 more |
Product
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph 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
Improper design or specifications.
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-0707-2019. 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.