Monaco Radiation Treatment Planning System (RTP) System
Class I - DangerousWhat Should You Do?
- 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
- 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:
- 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.govFDA Recall Number: Z-0670-2020
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.