Z-0550-2016Class II

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

Name: Z-0550-2016 Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-11-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-11-17 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging XS is a Picture Archiving and Communication System (PACS) on 2015-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0550-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2015-12-24
Terminated: 2016-12-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: 11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.
Quantity in commerce: 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 ;
Product codes and lots: Model number 10558586 Software version VB10C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0550-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0550-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

Product code LLZ

K082430Class IISyngo Imaging XsSiemens AG Medical Solutions / cleared 2008-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)