Device recall

Z-0164-2009: Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and…

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

Key facts

Recall number (Z-number) Z-0164-2009
Recall event 48661
Product Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for…
Product code IYE
Recalling firm Varian Medical Systems Oncology Systems
Recall class Class II
Status Terminated
Termination date May 3, 2011
510(k) numbers K001643
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)