FDA recall Z-2560-2019

Elekta Inc · Class II · device

Product

Monaco RTP System, 5.40 Unity, 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

Reason for recall

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2019-09-04
Report date
2019-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maryland Heights, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2560-2019