medical Class II Updated 2019-10-02

Elekta Inc recalls Monaco RTP System, 5.40 Unity, radiation treatment planning

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI (01)00858164002190(10) 5.40.00
View official government recall

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