Elekta, Inc. recalls MOSAIQ Medical Charged-Particle Radiation Therapy System

Recall date

June 30, 2017

Source

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

Recall number

Z-3110-2017

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide distribution. US nationwide to AK, AL, AR, AZ, CA, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. ALBANIA, ALGERIA, ANTIGUA AN…

Why it was recalled

The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

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

What was recalled

MOSAIQ Medical Charged-Particle Radiation Therapy System