Elekta, Inc. recalls Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam r…

Recall date

November 17, 2016

Source

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

Recall number

Z-0668-2017

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bul…

Why it was recalled

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

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 TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.