Class II — Siemens Medical Solutions USA Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 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. |
| Quantity | 1 unit |
| Distribution | Worldwide Distribution - US Nationwide and the countries of China and Malaysia. |
| Initiated | 2016-04-25 |
| Classified | 2016-06-15 |
| Terminated | 2017-02-01 |
| Recall number | Z-1997-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA Inc. (Z-1997-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74239/
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