Recall Z-1700-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza software 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 Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital
| Date | Feb 20, 2018 |
| Status | Terminated |
| Reason | Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. |
| Root cause | Software design |
| Action | On February 25, 2018 a Customer Information Letter was mailed to customers. This notification informed customers of the software changes related to All Sygno.plaza systems with VB20A. Customers were asked to install an updated software patch and instructed to share the notification with all users of the affected product. Customers with questions should call Siemens Customer Care Centre at (866)823-9702. For further questions, please call (610) 448-6461. |
| Quantity | 92 |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132532 | SYNGO.PLAZA VB10A Siemens AG Healthcare, Dec 9, 2013 |