Device recall

Z-2181-2011: Varian Medical System TrueBeam system for stereotactic radiosurgery and…

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

Key facts

Recall number (Z-number) Z-2181-2011
Recall event 58590
Product Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
Product code IYE
Recalling firm Varian Medical Systems, Inc. Oncology Systems
Recall class Class II
Status Terminated
Termination date Jun 19, 2012
510(k) numbers K092871
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)