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Varian Medical Systems Inc recalls Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Recalled July 1, 2015 · FDA recall Z-1829-2015 · Varian Medical Systems
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 · FDA Class II
Units
46
Sold at
Worldwide Distribution.
Description
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
Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Manufacturer(s)
Varian Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →