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 | Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. |
| Product | Biograph mCT Flow Edge-4R, Model Number 10528955 |
| Quantity | 3 units |
| Distribution | Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. |
| Initiated | 2015-07-14 |
| Classified | 2015-08-05 |
| Terminated | 2016-03-03 |
| Recall number | Z-2335-2015 |
| 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-2335-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71712/
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