Varian Multileaf Collimator

• 2 recalls, same reason

  • Terminated Z-1091-2012 FDA Not yet classified ·initiated 16 Jan 2012
  • Terminated Z-1090-2012 FDA Not yet classified ·initiated 16 Jan 2012

  When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.

510(k) Number

K943224 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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