Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2691-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 18, 2016

Date Posted: September 7, 2016

Recall Number: Z-2691-2016

Event ID: 74967

Reason for Recall:

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

Status: Terminated

Product Quantity: 13

Code Information:

iGuide 2.2.0

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated