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
___________________________________
