FDA Device recall Z-0862-2016
Syngo Plaza Picture archiving and communication system
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Syngo Plaza Picture archiving and communication system by Siemens Medical Solutions Usa, citing 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 enab….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0862-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-22 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Device model numbers: 10863171, 10863172, 10863173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0862-2016%22
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