Elekta, Inc. recalls Monaco Radiation Treatment Planning (RTP) System

Recall date

February 8, 2019

Source

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

Recall number

Z-0965-2019

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Why it was recalled

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

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 Radiation Treatment Planning (RTP) System