Recall Z-2560-2019— Elekta Inc
Class II · Ongoing
Class II FDA medical device recall by Elekta Inc, initiated 2019-09-04. It names one FDA 510(k) clearance: K183037. 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: 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
- Elekta Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-04
- Firm location
- Maryland Heights, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.