—#82994

Product

syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081734
Affected lot / code info: model number 10014063. Serial numbers: 1141, 1322, 1343, 1353, 1379, 1386, 1387, 1389, 1391, 1392, 1395, 1396, 1402, 1407, 1408, and 1417

Why it was recalled

Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

Root cause (FDA determination)

Software design

Action the firm took

syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2009-06-01
Posted by FDA: 2009-07-07
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.