System, Applicator, Radionuclide, Remote-controlled

Brand Name: Fletcher CT/MR Shielded Applicator Set

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Brand Name: Brachytherapy Applicator

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Brand Name: Geneva

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporat

After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).

Surface Applicator Set with Leipzig-style Cone.

Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat

VARISOURCE Breast Template System for high-dose rate Brachytherapy.

The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)

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

Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves

The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.