🔍 RecallPedia

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Class I - Dangerous
🏥 Medical Devices Recalled: July 3, 2019 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
  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:
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Product Codes/Lot Numbers:

all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2091-2019

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