Syngo — Class II medical device recall Z-1116-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-02-08, distributed nationwide. Software update for improvements and to resolve several issues
| Recall number | Z-1116-2017 |
|---|---|
| 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 | 2017-01-11 |
| Classified | 2017-01-31 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-11-16 |
| Distributed | Nationwide (US) |
| Quantity | 62 systems |
| Reason classes | software |
| Serial numbers | 100025, 100027, 100029, 100031, 100033, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100132, 100133, 100135, 100139, 100186, 100188, 100189 and 35 more |
| Model numbers | 10863171, 10863172, 10863173 |
Product
Syngo.plaza, picture archiving and communications system.
Reason for recall
Software update for improvements and to resolve 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-1116-2017. 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.