syngo Imaging XS Syngo Imaging XS is a Picture Archiving and… — Class II medical device recall Z-1622-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-05-28, distributed nationwide. A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and
| Recall number | Z-1622-2014 |
|---|---|
| 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 | 2014-04-03 |
| Classified | 2014-05-16 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 64 |
| Serial numbers | 1005, 1043, 1049, 1053, 1055, 1057, 1058, 1064, 1065, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1090, 1107, 1116, 1124, 1198, 1203, 1210, 1218 and 39 more |
Product
syngo Imaging XS Syngo Imaging XS 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 Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Reason for recall
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archiving method may have deleted data from archive itself.
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-1622-2014. 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.