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 | Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis. |
| Product | syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 |
| Quantity | 50 |
| Distribution | Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA. |
| Initiated | 2014-01-27 |
| Classified | 2014-03-18 |
| Terminated | 2015-03-16 |
| Recall number | Z-1216-2014 |
| 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-1216-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67559/
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