Z-2691-2016Class II

HexaPOD evo RT System

Name: Z-2691-2016 HexaPOD evo RT System
Creator: Elekta, Inc.
Published: 2016-08-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-08-18 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of 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... on 2016-08-18. FDA classified it as Class II and gives the reason as "Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2691-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Posted: 2016-08-30
Terminated: 2017-05-23
Recalling firm: Elekta Limited
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta sent an Important User Notice 618-03-303-025 to affected customers on 8/18/2016. The notice identified the affected product, problem, clinical impact, solution and actions to be taken. The Notice reminds users that the Interlock Check is not possible during 3D Workflow as iGUIDE is not in use. The notice reminds users that if iGUIDE is not being used - (A) Ensure the HexaPOD is at its pre-defined 3D position before treatment, and (B) Ensure the External Inhibit LED at the EnableSwitch Board is off. For questions contact your local Elekta office.
Quantity in commerce: 13
Distribution: Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
Product codes and lots: iGuide 2.2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2691-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2691-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code IYE

K072079Class IIIguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta / cleared 2007-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)