Syngo — Class II medical device recall Z-2719-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-09-09, distributed nationwide. Potential issue leading to data loss and patient data mix-up
| Recall number | Z-2719-2015 |
|---|---|
| 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 | 2015-07-06 |
| Classified | 2015-09-02 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2017-01-06 |
| Distributed | Nationwide (US) |
| Quantity | 37 |
| Serial numbers | 100138, 100146, 100174, 100177, 100181, 100198, 100263, 100301, 100302, 100491, 100492, 100499, 100539, 100544, 100571, 100596, 100600, 200251, 200252, 200277, 200308, 200309, 200310, 200311, 200312 and 12 more |
Product
Syngo.plaza; picture archiving and communications system 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 advanced postprocessing applications.
Reason for recall
Potential issue leading to data loss and patient data mix-up
Machine access
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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.