Elekta, Inc. recalls HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with…

Recall date

August 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2691-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.

Why it was recalled

Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.