—#126950

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033831, K042832, K052461
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Use error

Action the firm took

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. .

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-04-03
Posted by FDA: 2014-05-16
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.