Recall Z-0524-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structu
| Date | Aug 23, 2017 |
| Status | Terminated |
| Reason | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study. |
| Root cause | Software design |
| Action | Siemens Healthineers distributed Urgent Customer Advisory Notices to their customers via courier service. Customers were advised to always verify date and time of the displayed study during workflow step change to ensure that the desired images are being displayed. Otherwise, please replace the displayed initial study in the workflow step with the expected study. Customers with any questions, call Siemens Customer Care Centre at 888-826-9702. |
| Quantity | 76 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132532 | SYNGO.PLAZA VB10A Siemens AG Healthcare, Dec 9, 2013 |