ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250
- 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:
- Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Product Codes/Lot Numbers:
Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250
Distribution:
Distributed in: US, MO, WI, CA, FL, MI, NY, IL, MA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1803-2020
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.