Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Class I - DangerousWhat Should You Do?
- Check if you have this product: all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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.govFDA Recall Number: Z-2091-2019
Related Recalls
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Due to adapter not being properly aligned or locked in place.