Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1197-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 17, 2014

Date Posted: March 19, 2014

Recall Number: Z-1197-2014

Event ID: 67625

Reason for Recall:

Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.

Status: Terminated

Product Quantity: 1776

Code Information:

Versions 4.1 and higher

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated