FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
- Recall number
- Z-0550-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
- Status
- Terminated
- Initiated
- 2015-11-17
- Posted
- not on file
- Terminated
- 2016-12-05
- 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.
- 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
- 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 ;
- Lot, serial or model codes
- Model number 10558586 Software version VB10C
- 510(k) numbers
- ["K082430"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28