FDA Device recall Z-1622-2014
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, commun…
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, commun… by Siemens Medical Solutions Usa, citing 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 h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1622-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-03 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | material number: 10014063, with serial numbers: 1334 1065 1351 1491 1417 1269 1076 1043 1429 1353 1392 1258…material number: 10014063, with serial numbers: 1334 1065 1351 1491 1417 1269 1076 1043 1429 1353 1392 1258 1398 1445 1496 1279 1116 1090 1229 1080 1005 1081 1310 1246 1226 1057 1379 1396 1084 1322 1107 1453 1124 1343 1198 1432 1058 1247 1278 1082 1055 1049 1329 1203 1490 1083 1316 1395 1053 1079 1387 1448 1218 1451 1389 1386 1064 1500 1436 1074 1443 1210 1408 1427 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1622-2014%22
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