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.
Reported: May 22, 2013 Initiated: April 11, 2013 #Z-1324-2013
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.
Details
- Recalling Firm
- Varian Medical Systems, Inc.
- Units Affected
- 21 devices
- Distribution
- Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Varian Medical Systems, Inc.. Units affected: 21 devices.
Why was this product recalled? ▼
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2013. Severity: Moderate. Recall number: Z-1324-2013.
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