Company: Elekta, Inc.
Date of Enforcement Report: 2/11/2025
Class II
PRODUCT
MOSAIQ Oncology Information System
Recall Number:
Z-1162-2025
REASON:
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
RECALLING FIRM/MANUFACTURER:
Elekta, Inc.
VOLUME OF PRODUCT IN COMMERCE:
64 units
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
