Syngo Plaza picture archiving and communication system — Class II medical device recall Z-2793-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-09-21, distributed nationwide. Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM
| Recall number | Z-2793-2016 |
|---|---|
| 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 | 2016-08-02 |
| Classified | 2016-09-14 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 101 systems |
| Serial numbers | 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100033, 100034, 100084, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100132 and 74 more |
| Model numbers | 10592457, 10863171, 10863172, 10863173 |
Product
Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Reason for recall
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
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-2793-2016. 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.