Focal Sim radiation therapy treatment planning system
Class I - DangerousWhat Should You Do?
- Check if you have this product: Focal Release 4.80
- 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:
- Incorrect CT to ED when using the Monaco Image Statistics Tool.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Focal Sim radiation therapy treatment planning system
Product Codes/Lot Numbers:
Focal Release 4.80
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1244-2015
Related Recalls
Class I - Dangerous
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Class I - Dangerous
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.