Device 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.
Z-1324-2013
Product summary
- Event
- Event 64986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 devices
- Official record key
device-enforcement:Z-1324-2013
Official wording
Reason: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Code information: Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
Distribution pattern: Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Derived failure modes
-
Unknown
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.