Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Class I - DangerousWhat Should You Do?
- Check if you have this product: None as the product is software
- 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:
- Elekta, Inc.
- Reason for Recall:
- During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Product Codes/Lot Numbers:
None as the product is software
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0118-2013
Related Recalls
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Due to adapter not being properly aligned or locked in place.