Recall Z-1613-2014 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
| Date | May 13, 2014 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display. |
| Root cause | Software design |
| Action | Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue. |
| Quantity | 50 |
| Distribution | US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV. |
| FDA record | Open on fda.gov |