Elekta, Inc. recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Recall date

January 10, 2017

Source

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

Recall number

Z-1044-2017

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech…

Why it was recalled

Incorrect dose after editing beam number an wedge angle.

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 RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.