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 | If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. |
| Product | syngo Dynamics Version 9.5 |
| Quantity | 30 |
| Distribution | Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC. |
| Initiated | 2012-07-13 |
| Classified | 2012-08-17 |
| Terminated | 2013-07-15 |
| Recall number | Z-2219-2012 |
| 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-2219-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62581/
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