Syngo Plaza Picture archiving and communication system — Class II medical device recall Z-0862-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-03-02, distributed nationwide. Siemens is releasing an updated software version to address several software issues including RGB images will
| Recall number | Z-0862-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-12-22 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 68 |
| Reason classes | software |
| Model numbers | 10863171, 10863172, 10863173 |
Product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
Reason for recall
Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0862-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.