Syngo — Class II medical device recall Z-1354-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-04-08, distributed in FL, MA, WI. Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operati
| Recall number | Z-1354-2015 |
|---|---|
| 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 | 2015-02-18 |
| Classified | 2015-03-30 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-08-17 |
| Distributed | FL, MA, WI |
| Quantity | 4 |
| Serial numbers | 100029, 100033, 100177, 100181 |
Product
Syngo.plaza. 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.
Reason for recall
Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
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-1354-2015. 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.