ClearanceBrief
Recall Z-2891-2016 ยท LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

Syngo.plaza, Picture Archiving and Communication System

DateSep 27, 2016 (initiated Sep 6, 2016)
StatusTerminated
ReasonSoftware upgrade to eliminate several issues
Root causeSoftware design
ActionSiemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.
Quantity47 systems
DistributionDistributed Nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K093612SYNGO.PLAZA
Siemens AG Medical Solutions, Mar 4, 2010