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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Varian Medical Systems, Inc.
- Reason for Recall:
- Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1324-2013
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