MEVION S250 Radiation therapy system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Manufacturing Lot or Serial Number: S250-0004
  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:
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
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 Radiation therapy system

Product Codes/Lot Numbers:

Manufacturing Lot or Serial Number: S250-0004

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0767-2016

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