🔍 RecallPedia

Elekta Unity, Image-Guided Radiation Therapy System

Class I - Dangerous
🏥 Medical Devices Recalled: December 18, 2019 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035
  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:
Elekta, Inc.
Reason for Recall:
There have been reports of excessive heating in the MRL Gradient Connection Module.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Elekta Unity, Image-Guided Radiation Therapy System

Product Codes/Lot Numbers:

Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035

Distribution:

Distributed in: US, PA, NY, IA, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2473-2020

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