Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model #10000, Serial #'s: 100, 101, and 102
- 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 Incorporated
- Reason for Recall:
- ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Product Codes/Lot Numbers:
Model #10000, Serial #'s: 100, 101, and 102
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2085-2015
Related Recalls
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Viewray Incorporated
The system loaded a completion fraction in the incorrect order after a treatment interruption.
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.