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Elekta Inc recalls Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make
Recalled May 6, 2020 · FDA recall Z-1825-2020 · Elekta
Hazard
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose. · FDA Class II
Units
96 devices
Sold at
Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
Description
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Product
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Manufacturer(s)
Elekta Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →