Syngo Imaging XS is a Picture Archiving and Communication System — Class II medical device recall Z-0550-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-12-30, distributed in AL, CA, CO, CT, FL, GA, IA, IL…. For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical s
| Recall number | Z-0550-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-12-05 |
| Distributed | AL, CA, CO, CT, FL, GA, IA, IL, IN, KS, MD, MI, MO, NC, NE, NJ, NV, NY, OH, PA, TN, TX, WI |
| Quantity | 42 |
| Reason classes | software |
| Model numbers | 10558586 |
Product
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.