FDA Medical Device Recalls (openFDA)
Elekta, Inc.: XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
- Recall number
- Z-0780-2014
- Recalling firm
- Elekta, Inc.
- Product
- XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
- Status
- Terminated
- Initiated
- 2013-11-25
- Posted
- 2014-01-17
- Terminated
- 2014-05-13
- Reason
- When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
- Root cause
- Software Design Change
- Action
- An Important Safety Notice, LINXIO0017 Proton Sport Beams, Changes in Fractionation not Updating Dose, is in the process of being distributed to affected customers. The release date for this notice is November 25, 2013. The notice included a Confirmation of Receipt which was to be returned to Elekta. For further questions please call (404) 993-5886.
- Quantity
- 13
- Distribution
- Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
- Lot, serial or model codes
- Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
- 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