Elekta, Inc. recalls MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for…

Recall date

December 4, 2018

Source

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

Recall number

Z-0686-2019

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Mya…

Why it was recalled

If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.

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

What was recalled

MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery