Recall Z-1216-2014 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
| Date | Mar 18, 2014 (initiated Jan 27, 2014) |
| Status | Terminated |
| Reason | Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis. |
| Root cause | Software design |
| Action | A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014. |
| Quantity | 50 |
| Distribution | Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA. |
| FDA record | Open on fda.gov |