Recall Z-1027-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza: 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/Radiolo
| Date | Jan 28, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300. |
| Quantity | 50 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |