ClearanceBrief
Recall Z-1689-2017 ยท LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

Syngo.via, 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, fo

DateMar 27, 2017 (initiated Mar 6, 2017)
StatusTerminated
ReasonSoftware changes now available to address several issues
Root causeSoftware design
ActionSiemens 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.
Quantity104
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K123375SYNGO.VIA
Siemens AG, Nov 20, 2012