Recall Z-0071-2007 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Sienet Sky, picture archiving and communications system. Model number 8463163
| Date | Oct 25, 2006 (initiated Sep 5, 2006) |
| Status | Terminated |
| Reason | Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended. |
| Root cause | Other |
| Action | The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence. |
| Quantity | 1818 units total, for all three products |
| Distribution | The product was shipped to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935694 | SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE Siemens Medical Solutions USA, Inc., Mar 7, 1994 |