MEVION S250 Product Usage: Proton Radiation Therapy System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: S250-0001 through S250-0006
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Mevion Medical Systems, Inc.
Reason for Recall:
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

MEVION S250 Product Usage: Proton Radiation Therapy System

Product Codes/Lot Numbers:

Serial Numbers: S250-0001 through S250-0006

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0411-2017

Related Recalls