Recall Z-0514-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo Imaging XS, all versions Radiological image processing system
| Date | Jan 11, 2012 (initiated Sep 20, 2011) |
| Status | Terminated |
| Reason | Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system. |
| Root cause | Labeling False and Misleading |
| Action | Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 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 inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834. |
| Quantity | 38 |
| Distribution | Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |