Medical device recalls Moderate risk

Elekta, Inc. recalls Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam ra…

Recall date
October 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0181-2016
FDA classification
Class II
Brand / firm
Elekta, Inc.
Sold / distributed
CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom

Why it was recalled

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

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 used to make treatment plans for patients with prescriptions for external beam radiation therapy.

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