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Terminated

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

FDA Recall Z-0550-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-11-17
Date Terminated2016-12-05
Product Quantity42

Reason for Recall

For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using 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 Imaging XS printer configuration file.

Firm Action

11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.

Root Cause

Software in the Use Environment

Distribution Pattern

AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082430SYNGO IMAGING XSSiemens AG Medical Solutions · 2008-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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