Device recall

Z-0945-2012: Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf…

FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems

Key facts

Recall number (Z-number) Z-0945-2012
Recall event 61012
Product Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC)…
Product code IYE
Recalling firm Varian Medical Systems, Inc. Oncology Systems
Recall class Class II
Status Terminated
Termination date Feb 19, 2015
510(k) numbers K990085
FEI number 2916710

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)