Recall Z-1354-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza. 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.
| Date | Mar 30, 2015 (initiated Feb 18, 2015) |
| Status | Terminated |
| Reason | Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived. |
| Root cause | Software design |
| Action | Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS. |
| Quantity | 4 |
| Distribution | US Distribution: MA, WI, FL |
| FDA record | Open on fda.gov |