ClearanceBrief
Recall Z-1206-06 ยท IYE Accelerator, Linear, Medical

Varian Medical Systems Inc

Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.

DateJul 6, 2006 (initiated Jun 6, 2006)
StatusTerminated
ReasonMachine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
Root causeOther
ActionThe firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.
Quantity217 units
DistributionWorldwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K862645CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)
Varian Assoc., Inc., Oct 3, 1986