FDAFDA · Food and drugs·Recall number Z-2561-2019
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Published October 2, 2019 · Recall initiated: September 4, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Elekta Inc
- Distributor
- Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
- Lot
- UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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