Cl II Siemens Syngo Imaging XS

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 12/30/2015
Class lI:

PRODUCT

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Recall Number Z-0550-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/17/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
42

DISTRIBUTION
US Distribution

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.