Device recall

Z-0526-2015: Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is…

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

Key facts

Recall number (Z-number) Z-0526-2015
Recall event 69637
Product Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land marks.
Product code IYE
Recalling firm Varian Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Mar 16, 2015
510(k) numbers 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

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