Device recall

Z-2308-2008: Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan…

FDA device recall · Class II · Varian Medical Systems Oncology Systems

Key facts

Recall number (Z-number) Z-2308-2008
Recall event 48730
Product Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments.
Product code IYE
Recalling firm Varian Medical Systems Oncology Systems
Recall class Class II
Status Terminated
Termination date Mar 10, 2011
510(k) numbers K010975
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)