FDA Device recall Z-1027-2015
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di…
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di… by Siemens Medical Solutions Usa, citing in case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power ou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1027-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-13 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Syngo.plaza: 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 advanced postprocessing applications
Reason
In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.
Identifiers
| code_info | Model Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial 100544 100262 100198 100258 2…Model Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial 100544 100262 100198 100258 200211 100135 100133 100213 100031 100084 100233 100140 200308 100245 100314 100139 100177 100197 100170 100025 100174 100186 100033 100306 100232 100185 100256 100199 100188 100257 100198 100226 100198 100228 100181 100029 100253 100301 100203 100132 100139 100247 100215 100230 100221 100146 100207 100212 100539 100206 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1027-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.