Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0130-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: October 28, 2015

Recall Number: Z-0130-2016

Event ID: 72223

Reason for Recall:

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Status: Terminated

Product Quantity: 1440 units

Code Information:

Version 4.51 and higher

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated