Date Initiated by Firm | April 03, 2014 |
Date Posted | May 16, 2014 |
Recall Status1 |
Terminated 3 on December 15, 2014 |
Recall Number | Z-1622-2014 |
Recall Event ID |
68107 |
510(K)Number | K033831 K042832 K052461 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer 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 Determined Cause 2 | 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.
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Quantity in Commerce | 64 |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LLZ
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