Radiation Therapy Treatment Planning System, Model 5.0
Class I - DangerousWhat Should You Do?
- Check if you have this product: 5.0.0.37, 5.0.1.11 and 5.0.2.35
- 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:
- For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Radiation Therapy Treatment Planning System, Model 5.0
Product Codes/Lot Numbers:
5.0.0.37, 5.0.1.11 and 5.0.2.35
Distribution:
Distributed in: AZ, CA, FL, MT, NC, NY, TX, OH, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0079-2017
Related Recalls
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.