🔍 RecallPedia

Monaco Radiation Treatment Planning System (RTP) System

Class I - Dangerous
🏥 Medical Devices Recalled: November 22, 2019 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
  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:
Monaco is using the incorrect energy when optimizing and calculating dose.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Monaco Radiation Treatment Planning System (RTP) System

Product Codes/Lot Numbers:

Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00

Distribution:

Distributed in: IA, IN, NY, OH, TX, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0670-2020

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