Home / Recalls / Medical Devices
Elekta, Inc. recalls HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning w
Recalled September 7, 2016 · FDA recall Z-2691-2016 · Elekta
Hazard
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position. · FDA Class II
Units
13
Sold at
Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
Description
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
Product
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.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →