Z-0130-2016Class II

XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom...

Name: Z-0130-2016 XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom...
Creator: Elekta, Inc.
Published: 2015-08-31
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-08-31 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has... on 2015-08-31. FDA classified it as Class II and gives the reason as "Incorrect Treatment Delivery Using Third Party Fixed Wedges". 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-0130-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-10-16
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning 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: Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified via URGENT FIELD SAFETY ALERT, on 08/31/2015.
Quantity in commerce: 1440 units
Distribution: Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.
Product codes and lots: Version 4.51 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0130-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0130-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-16

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)