FDAClass IIDecember 30, 2015

Syngo Imaging XS is a Picture Archiving and recall: Software Issue

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

Why was Syngo Imaging XS is a Picture Archiving and recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number 10558586 Software version VB10C

Product
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
42
Distribution
AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;
Recall date
December 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls