RecallRadar

FDA Device recall Z-0550-2016

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

On 2015-12-30 the FDA classified a Class II recall of Syngo Imaging XS is a Picture Archiving and Communication System (PACS) by Siemens Medical Solutions Usa, citing 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 wi….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0550-2016
ClassificationClass II
Statusterminated
Initiated2015-11-17
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionAL, CA, CO, CT, FL, GA, IA, IL, IN, KS, MD, MI, MO, NC, NE, NJ, NV, NY, OH, PA, TN, TX, WI

Product

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

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.

Identifiers

code_infoModel number 10558586 Software version VB10C

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0550-2016%22

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