Varian Medical Systems Inc recalls Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

Recall date

May 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1829-2015

FDA classification

Class II

Brand / firm

Varian Medical Systems Inc

Sold / distributed

Worldwide Distribution.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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