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FDAOctober 25, 2023device

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

elekta

UPCs

0506019107151205060191071543

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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