Elekta, Inc. recalls MOSAIQ Oncology Information System

Recall date

January 15, 2025

Source

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

Recall number

Z-1162-2025

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela

Why it was recalled

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

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