syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system
FDA device recall Z-0515-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series.
- Action taken
- Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory letter dated August 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistenceis in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 12
- Distribution
- Nationwide Distribution including the states of CA, IN, IA, NV, NE, NY, OH, TN and TX.
- Date initiated
- 2011-09-19
- Date posted
- 2012-01-11
- Date terminated
- 2014-01-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |