Dec

2015

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Siemens Syngo Imaging XS

Amy Sellers

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