FDA-Device2023-12-13Class II
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
Hazard
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.
Sold states
worldwide
Affected count
291 units
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2024Don't want to check this manually?
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