Biograph mCT S — Class II medical device recall Z-0811-2015
Terminated recall by Siemens Medical Solutions USA Inc., reported 2014-12-24, distributed in MA, NC. Possibility for system display freeze during CT interventional procedures.
| Recall number | Z-0811-2015 |
|---|---|
| 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 | 2014-11-13 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-07-09 |
| Distributed | MA, NC |
| Countries outside the US | AU, CA, CH, DE |
| Quantity | 8 units |
| Serial numbers | 11042 |
Product
Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT 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
Possibility for system display freeze during CT interventional procedures.
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-0811-2015. 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.