🔍 RecallPedia

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Class I - Dangerous
🏥 Medical Devices Recalled: July 26, 2021 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
  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:
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
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 Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Product Codes/Lot Numbers:

Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10

Distribution:

Distributed in: US, IA, NJ, NY, TN, PA, TX, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2406-2021

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