Syngo — Class II medical device recall Z-1027-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-02-04, distributed nationwide. In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies i
| Recall number | Z-1027-2015 |
|---|---|
| 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 | 2015-01-13 |
| Classified | 2015-01-28 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2017-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Serial numbers | 100025, 100029, 100031, 100033, 100084, 100132, 100133, 100135, 100139, 100140, 100146, 100170, 100174, 100177, 100181, 100185, 100186, 100188, 100197, 100198, 100199, 100203, 100206, 100207, 100212 and 22 more |
| Model numbers | 10592457, 10863171, 10863172, 10863173 |
Product
Syngo.plaza: 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
In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.
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-1027-2015. 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.