FDA Medical Device Recalls (openFDA)
Elekta, Inc.: iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
- Recall number
- Z-1807-2014
- Recalling firm
- Elekta, Inc.
- Product
- iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
- Status
- Terminated
- Initiated
- 2014-05-29
- Posted
- 2014-06-17
- Terminated
- 2017-09-29
- Reason
- A bug in the software prevents the iGUIDE software from logging off.
- Root cause
- Software design
- Action
- Elekta sent an Important Field Safety Notice 618 01 303 024 dated May 29, 2014 to affected customers. The letter identified the affected product, problem, potential clinical impact and actions to be taken. It also gives a recommendation how the risk can be mitigated - Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. The notice also advises the customer that a patch will be released that corrects the behavior of the iGUIDE software. This solution will be implemented on all affected products when available. For questions contact your local Elekta office.
- Quantity
- 224
- Distribution
- Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam
- Lot, serial or model codes
- Software Versions 2.0.0, 2.0.1 and 2.0.2
- 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