Recall Z-1972-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
| Date | Jul 2, 2015 (initiated Jun 11, 2015) |
| Status | Terminated |
| Reason | During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size. |
| Root cause | Software design |
| Action | Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary. |
| Quantity | 5 |
| Distribution | US in the states of NC and NE |
| FDA record | Open on fda.gov |