PlainRecalls
FDA Devices Moderate Class II Ongoing

Monaco RTP System, 5.50/5.51, 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 planni

Reported: October 2, 2019 Initiated: September 4, 2019 #Z-2561-2019

Product Description

Monaco RTP System, 5.50/5.51, 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.

Details

Recalling Firm
Elekta Inc
Units Affected
49 units
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
Location
Maryland Heights, MO

Frequently Asked Questions

What product was recalled? ▼
Monaco RTP System, 5.50/5.51, 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. Recalled by Elekta Inc. Units affected: 49 units.
Why was this product recalled? ▼
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2019. Severity: Moderate. Recall number: Z-2561-2019.

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