MRIdian Linac Radiation Therapy System, Model 20000.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
- 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:
- Viewray, Inc.
- Reason for Recall:
- A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MRIdian Linac Radiation Therapy System, Model 20000.
Product Codes/Lot Numbers:
Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
Distribution:
Distributed in: FL, IL, MI, MO, NY, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1251-2019
Related Recalls
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.