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 | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures |
| Product | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system |
| Quantity | 14 US |
| Distribution | US in the states of: GA, IN, MO, MS, NJ, OH, PA |
| Initiated | 2019-09-24 |
| Classified | 2019-11-21 |
| Terminated | 2024-07-08 |
| Recall number | Z-0265-2020 |
| 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-0265-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83883/
Alerts for SIEMENS MEDICAL SOLUTIONS USA, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.