Recall Z-1324-2013— Varian Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2013-04-11, terminated 2014-01-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target..
- Recalling firm
- Varian Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-11
- Terminated
- 2014-01-13
- Firm location
- Charlottesville, VA, United States
Product description
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.
Reason for recall
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Data sourced from openFDA. This site is unofficial and independent of the FDA.