Recall Z-1688-2017 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for
| Date | Mar 27, 2017 (initiated Mar 6, 2017) |
| Status | Terminated |
| Reason | Software changes now available to address several issues |
| Root cause | Software design |
| Action | Siemens sent a notice dated March 7, 2017, to affected customers on to inform them that software updates via the latest syngo.via software was now available to that would address several issues that were reported. Customers were asked to forward the notice to the new owner. For questions regarding this recall call 610-448-6481. |
| Quantity | 104 systems |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092519 | SYNGO.X Siemens AG Medical Solutions, Aug 27, 2009 |