—#80715

Product

syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056.

Why it was recalled

An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).

Root cause (FDA determination)

Software design

Action the firm took

A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.

Timeline

Recall initiated: 2009-02-09
Posted by FDA: 2009-04-28
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80715. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.