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 | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study. |
| Product | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advan… |
| Quantity | 76 |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-08-23 |
| Classified | 2018-02-05 |
| Terminated | 2018-10-01 |
| Recall number | Z-0524-2018 |
| 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-0524-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78677/
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