Syngo — Class II medical device recall Z-2891-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-10-05, distributed nationwide. Software upgrade to eliminate several issues
| Recall number | Z-2891-2016 |
|---|---|
| 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 | 2016-09-06 |
| Classified | 2016-09-27 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 47 systems |
| Reason classes | software |
| Serial numbers | 100025, 100027, 100029, 100031, 100033, 100084, 100132, 100133, 100139, 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100198, 100199, 100203, 100204, 100206, 100213, 100214, 100228, 100232 and 21 more |
Product
Syngo.plaza, Picture Archiving and Communication System
Reason for recall
Software upgrade to eliminate several issues
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-2891-2016. 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.