Elekta, Inc. recalls Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Recall date

August 18, 2016

Source

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

Recall number

Z-2712-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh,…

Why it was recalled

In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

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 Used to make treatment plans for patients with prescriptions for external beam radiation therapy.