Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
FDA Recall Z-0576-2015 · Posted 2014-12-15
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-11-11
Date Terminated2015-02-24
Product Quantity149
Reason for Recall
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
Firm Action
Siemens sent a Safety Advisory notices letter dated November 11, 2014 to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions call 1-888-826-9702.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.