FDA-Device2013-05-22Class II
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Varian Medical Systems, Inc.
Hazard
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Sold states
Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Affected count
21 devices
Manufactured in
700 Harris St Ste 109, Charlottesville, VA, United States
Products
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2013Don't want to check this manually?
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