Recall – Radiation treatment planning system settings unintentionally result in incorrect dose calculation

Company: Elekta Inc
Date of Enforcement Report: 10/2/2019
Class II


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

  • Recall Number: Z-2560-2019


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


Elekta Inc on 9/4/2019. Voluntary:  Firm Initiated recall is ongoing.


30 units


US Nationwide and International

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.