BIOGRAPH mCT S — Class II medical device recall Z-1999-2016
Terminated recall by Siemens Medical Solutions USA Inc., reported 2016-06-22, distributed nationwide. The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to
| Recall number | Z-1999-2016 |
|---|---|
| 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 | 2016-04-25 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, MY |
| Quantity | 1 units |
| Serial numbers | 11009 |
Product
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: 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
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
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-1999-2016. 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.