FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions 4.70.00 & 4.80.00
- 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:
- When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
- 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 Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Product Codes/Lot Numbers:
Software versions 4.70.00 & 4.80.00
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2574-2014
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