ClearanceBrief
Recall Z-1490-2017 ยท IYE Accelerator, Linear, Medical

Siemens Medical Solutions USA, Inc

ONCOR" Avant-garde

DateFeb 14, 2017
StatusTerminated
ReasonSoftware update
Root causeSoftware design
ActionSiemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
Quantity80 systems
DistributionDistributed throughout the United States
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
Siemens Medical Solutions USA, Inc., Sep 5, 2003