Elekta, Inc. recalls Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation…

Recall date

April 19, 2016

Source

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

Recall number

Z-1561-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republi…

Why it was recalled

The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.

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

What was recalled

Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.