11
Feb
2025

FDA Recall: Image offsets Calculations May be Incorrect for Linear Accelerator

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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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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