Syngo — Class II medical device recall Z-1533-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-03-29, distributed nationwide. Software updates
| Recall number | Z-1533-2017 |
|---|---|
| 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 | 2017-02-20 |
| Classified | 2017-03-22 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 13 systems |
| Reason classes | software |
| Serial numbers | 100212, 100213, 100221, 100247, 100300, 100306, 100307, 100314, 100362, 100449, 100450, 100457, 100484 |
| Model numbers | 10863171, 10863173 |
Product
Syngo.plaza, Picture Archiving and Communications System (PACS) 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
Software updates
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-1533-2017. 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.