FDAFDA · Food and drugs·Recall number Z-1324-2013
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.
Published May 22, 2013 · Recall initiated: April 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc.
- Distributor
- Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
- Lot
- Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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