Elekta, Inc. recalls Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam r…

Recall date

September 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0076-2017

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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