FDA Medical Device Recalls (openFDA)
Elekta, Inc.: iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
- Recall number
- Z-3017-2017
- Recalling firm
- Elekta, Inc.
- Product
- iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
- Status
- Terminated
- Initiated
- 2017-06-19
- Posted
- not on file
- Terminated
- 2019-11-05
- Reason
- Incorrect PEC values.
- Root cause
- Unknown/Undetermined by firm
- Action
- Elekta sent an Urgent Important Field Safety Notice 618-01-303-026 letter dated June 2017 to all affected customers. The letter identified the affected product, problem, the potential clinical impact and actions to be taken.. It also provides a workaround to avoid the issue.
- Quantity
- 110 units
- Distribution
- Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, & Vietnam.
- Lot, serial or model codes
- Scope; iGUIDE 2.2.0, iGUIDE 2.2.1
- 510(k) numbers
- ["K143485"]
- 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