Class II

Medical Device Recall: MOSAIQ Oncology Information System

Elekta, Inc. · January 15, 2025

Reason for Recall

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

Distribution

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

States Affected

AL, FL, IA, PA, UT

Quantity Affected

64 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1162-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.