Elekta, Inc. recalls XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam r…

Recall date

August 31, 2015

Source

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

Recall number

Z-0130-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Ca…

Why it was recalled

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

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

What was recalled

XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.