Device recall

Z-1195-2007: Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam…

FDA device recall · Class II · Varian Medical Systems Inc

Key facts

Recall number (Z-number) Z-1195-2007
Recall event 38349
Product Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
Product code IYE
Recalling firm Varian Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Aug 12, 2010
510(k) numbers K040192, K041519, K042720
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)