Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. Recalled by Varian Medical Systems Inc Due to Varian has discovered that there is a discrepancy...

Date: May 18, 2015
Company: Varian Medical Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Varian Medical Systems Inc directly.

Affected Products

Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

Quantity: 46

Why Was This Recalled?

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

Where Was This Sold?

Worldwide Distribution.

About Varian Medical Systems Inc

Varian Medical Systems Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report