FDA Medical Device Recalls (openFDA)
Elekta, Inc.: XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
- Recall number
- Z-0928-2014
- Recalling firm
- Elekta, Inc.
- Product
- XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
- Status
- Terminated
- Initiated
- 2013-11-25
- Posted
- 2014-02-04
- Terminated
- 2015-12-02
- Reason
- When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
- Root cause
- Software design
- Action
- Corrective Action 1 - An important safety notice, LINXIO0018 - Incorrect Effective Depth for Bolused Beams is in the process of being distributed to affected customers. (Release date November 25, 2013). Corrective Action 2 - Develop a fix to the defect in an expeditious timeframe and make available in Patch Release 4.0.03 and Release 5.00.01.
- Quantity
- 1424
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Argentina, Austria, Australia, Bosnia, Bulgaria, Belgium, Bahrain, Brazil, Belarus, Botswana, Bangladesh, Canada, China, Columbia, Costa Rica, Croatia, Cuba, Cyprus, Chile, Czech Republic, Ecuador, Egypt, Estonia, France, Finland, Gabon, Germany, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Italy, Ireland, Israel, Iraq, Jordan, Japan, Kosovo, Kuwait, Lithuania, Libya, Latvia, Morocco, Malaysia, Malta, Mexico, Myanmar, Netherland, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sudan, Syria, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, Venezuela, and Vietnam.
- Lot, serial or model codes
- MUJ
- 510(k) numbers
- ["K102216"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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