syngo.plaza Image processing system
FDA device recall Z-0522-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.
- Action taken
- Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1
- Distribution
- Nationwide Distribution New York
- Date initiated
- 2011-09-21
- Date posted
- 2012-01-11
- Date terminated
- 2014-01-31
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |