The Recall Desk
HighFDA (Devices)·Z-2691-2016·Announced 2016-09-07

Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (radiotherapy positioning) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Elekta, Inc. is recalling 13 HexaPOD evo RT Systems. These devices are used to control accurate patient positioning with the assistance of a 3D Tracking System in a radiotherapy environment. The recall is due to a potential issue where the treatment couch may not move fully to the 3D position, resulting in an unrecognized incorrect position during the 3D workflow.

The affected units are distributed worldwide, including in the United States (Louisiana, Pennsylvania, and Washington) and in Australia, Denmark, France, India, Italy, and Japan. The specific software version associated with this recall is iGuide 2.2.0.

Healthcare facilities and users of these systems should contact Elekta for instructions on how to address the positioning issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

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
Elekta, Inc.
Category
Medical Device — Radiotherapy Positioning
Hazard
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • iGuide 2.2.0

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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