🔍 RecallPedia

Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Class I - Dangerous
🏥 Medical Devices Recalled: April 10, 2017 Ion Beam Applications S.A. Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    Serial numbers: PAT.003, PAT.006
  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:
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Product Codes/Lot Numbers:

Serial numbers: PAT.003, PAT.006

Distribution:

Distributed in: FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2097-2017

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