FDA-Device2015-07-01Class II
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Varian Medical Systems Inc
Hazard
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
Sold states
Worldwide Distribution.
Affected count
46
Manufactured in
501 Locust Ave, Charlottesville, VA, United States
Products
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1829-2015Don't want to check this manually?
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