—#142336

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082430
Affected lot / code info: Model number 10558586 Software version VB10C

Why it was 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.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;

Timeline

Recall initiated: 2015-11-17
Terminated: 2016-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.