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Elekta, Inc. recalls Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam r
Recalled October 19, 2016 · FDA recall Z-0076-2017 · Elekta
Hazard
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly. · FDA Class II
Units
365
Sold at
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Description
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Product
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →