Elekta Limited recalls Integrity R1.2

Recall date

November 20, 2017

Source

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

Recall number

Z-0724-2018

FDA classification

Class II

Brand / firm

Elekta Limited

Sold / distributed

Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA…

Why it was recalled

Potential for positional errors following automatic table movement (ATM).

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

What was recalled

Integrity R1.2