Device recall

Z-0545-2008: Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation…

FDA device recall · Class II · Varian Medical Systems Inc

Key facts

Recall number (Z-number) Z-0545-2008
Recall event 45520
Product Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system; Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC -- Stereotactic motion disable Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
Product code IYE
Recalling firm Varian Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Nov 27, 2010
510(k) numbers K070094
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

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