Z-1622-2014Class II

syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display...

Name: Z-1622-2014 syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-04-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-03 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute... on 2014-04-03. FDA classified it as Class II and gives the reason as "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 archivingmethod may have deleted data from archive itself". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1622-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2014-05-16
Terminated: 2014-12-15
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
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 archivingmethod may have deleted data from archive itself.
FDA root cause: Use error
Action: Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link. Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300. .
Quantity in commerce: 64
Distribution: Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1622-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1622-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)