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Varian Medical Systems, Inc. recalls Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: U
Recalled May 22, 2013 · FDA recall Z-1324-2013 · Varian Medical Systems
Hazard
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. · FDA Class II
Units
21 devices
Sold at
Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Description
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Product
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.
Manufacturer(s)
Varian Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →