Z-1197-2014Class II

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

Name: Z-1197-2014 XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external...
Creator: Elekta, Inc.
Published: 2014-02-17
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-02-17 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of XiO RPT 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 2014-02-17. FDA classified it as Class II and gives the reason as "Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs". 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-1197-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-17
Posted: 2014-03-13
Terminated: 2015-07-21
Recalling firm: Elekta Limited
Product: XiO RPT 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
Root cause tag: software
FDA root cause: Software design
Action: Elekta, Inc. issued an Important Safety Notice (LINXi000019) issued February 14, 29, 2014. The Safety Notice identified the product, the problem, and the action to be taken by the customer. All affected customers of the issue globally by February 28, 2014. Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix. Version 5.00.01 will be released for the fix in March 2014. Follow up with the affected customers for confirmation receipt of the LIN, and confirmation of installation of patch for the fix by November 30, 2014. For questions regarding this recall call 770-670-2422.
Quantity in commerce: 1776
Distribution: USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and Internationally to Albania, Algeria, Argentina, Australia, Austria, Bahamas, Barbados, Bermuda, British Guiana, Boliva, Brazil, British West Indies, Burundi, Canada, Chile, China, Columbia, Costa Rica, Cuba, Curacao, Cyprus, Czechoslovakia, Dominica, Equator, Estonia, Egypt, Finland, France, Gambia, Germany, Great Britain, Georgia, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lativa, Lithunia, Madagascar, Malaysia, Malta, Mexico, Mongolia, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, San Salvador, Saudia Arabia, Serbia, Singapore, Sir Lanka, South Korea, Spain, Sudan Slovenia, Suriname, Tajikistan, Thailand, Turkey, Turkmenistan, Taiwan, Ukraine, Uruguay, Venezuela, Viet Nam, Zambia.
Product codes and lots: Versions 4.1 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1197-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1197-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13

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)