Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0447-2024 — ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

U.S. FDA — Device Enforcement · United States · 2023-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0447-2024
Date of alert
2023-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Reported risk: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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