Device recall

Z-1324-2013: Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose…

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

Key facts

Recall number (Z-number) Z-1324-2013
Recall event 64986
Product Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Product code JAQ
Recalling firm Varian Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Jan 13, 2014
FEI number 3000206172

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)