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

Company: Elekta, Inc.
Date of Enforcement Report: 2/11/2025
Class II

PRODUCT

Recall Number:

REASON:

Elekta, Inc.

VOLUME OF PRODUCT IN COMMERCE:

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