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Elekta, Inc. recalls Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external
Recalled October 14, 2015 · FDA recall Z-0112-2016 · Elekta
Hazard
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. · FDA Class II
Units
154 units
Sold at
Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
Description
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →