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Elekta, Inc. recalls ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac
Recalled December 13, 2023 · FDA recall Z-0442-2024 · Elekta
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. · FDA Class II
Units
315 units
Sold at
worldwide
Description
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.
Product
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →