Recall Z-0443-2024— Elekta, Inc.

Name: FDA recall Z-0443-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-25

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2023-10-25. It names one FDA 510(k) clearance: K210500. Product: ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear. Reason: 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-25
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited·cleared 2021-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.