Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communicati
FDA device recall Z-0576-2015 · posted 2014-12-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Printouts may be printed in incorrect anatomical size when using syngo.plaza or 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.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
- Action taken
- Siemens sent a Safety Advisory notices letter dated November 11, 2014 to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions call 1-888-826-9702.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 149
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-11-11
- Date posted
- 2014-12-15
- Date terminated
- 2015-02-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA VB10A (K132532) | Siemens AG Healthcare | 2013-12-09 |
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |