FDA Medical Device Recalls (openFDA)
Elekta, Inc.: iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Recall number
- Z-1705-2016
- Recalling firm
- Elekta, Inc.
- Product
- iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Status
- Terminated
- Initiated
- 2016-05-12
- Posted
- 2016-05-23
- Terminated
- 2021-07-16
- Reason
- If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
- Root cause
- Software design
- Action
- Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.
- Quantity
- 20
- Distribution
- IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
- Lot, serial or model codes
- Software iGUIDE 2.1 and 2.2
- 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