🔍 RecallPedia

Proteus 235 Proton Therapy System for cancer treatment.

Class I - Dangerous
🏥 Medical Devices Recalled: March 27, 2014 Ion Beam Applications S.A. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.
  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:
Ion Beam Applications S.A.
Reason for Recall:
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Proteus 235 Proton Therapy System for cancer treatment.

Product Codes/Lot Numbers:

PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0020-2015

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