Z-0928-2014Class II

XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation...

Name: Z-0928-2014 XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation...
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. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed on 2013-11-25. FDA classified it as Class II and gives the reason as "When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect". 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-0928-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-02-04
Terminated: 2015-12-02
Recalling firm: Elekta Limited
Product: XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: MUJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0928-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0928-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-04

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)