ClearanceBrief
Recall Z-0808-2018 ยท LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

Syngo.via systems with SW VB20A

DateAug 31, 2017
StatusTerminated
ReasonA software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
Root causeSoftware Design Change
ActionOn August 25, 2017 an URGENT letter was issued to customers notify of a system update for Syngo.via systems with SW VB20A. The software was released on August 22, 2017. Several bugs and inconsistent diagnoses were detected and this software is intended to correct these. If you have any questions, call Siemens Customer Care Centre at 888-826-9702 (24/7).
Quantity30
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K123375SYNGO.VIA
Siemens AG, Nov 20, 2012