Elekta, Inc. recalls Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with…

Recall date

December 19, 2014

Source

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

Recall number

Z-1237-2015

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Aus…

Why it was recalled

Incorrect CT to ED when using the Monaco Image Statistics Tool.

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 radiation therapy treatment planning 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 and electron 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.