FDA Medical Device Recalls (openFDA)
Elekta, Inc.: 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.
- Recall number
- Z-2691-2016
- Recalling firm
- Elekta, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-08-18
- Posted
- 2016-08-30
- Terminated
- 2017-05-23
- Reason
- 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
- 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
- 13
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
- Lot, serial or model codes
- iGuide 2.2.0
- 510(k) numbers
- ["K072079"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28