Company: Elekta Inc
Date of Enforcement Report: 10/2/2019
Class II
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
- Recall Number: Z-2560-2019
REASON
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
RECALLING FIRM/MANUFACTURER
Elekta Inc on 9/4/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
US Nationwide and International