Z-0780-2014Class II

XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external...

Name: Z-0780-2014 XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external...
Creator: Elekta, Inc.
Published: 2013-11-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-11-25 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of 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... on 2013-11-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0780-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-01-17
Terminated: 2014-05-13
Recalling firm: Elekta Limited
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0780-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-17

Product code MUJ

K102216Class IIXio Rtp SystemComputerized Medical Systems, Inc. / cleared 2010-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)