Varian Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1324-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 11, 2013

Date Posted: May 22, 2013

Recall Number: Z-1324-2013

Event ID: 64986

Reason for Recall:

Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

Status: Terminated

Product Quantity: 21 devices

Code Information:

Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387

Distribution Pattern:

Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated