Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
- 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:
- RAYSEARCH LABORATORIES AB
- Reason for Recall:
- Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Product Codes/Lot Numbers:
Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0281-2014
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