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Terminated

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.

FDA Recall Z-1197-2014 · Posted 2014-03-13

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-02-17
Date Terminated2015-07-21
Product Quantity1776

Reason for Recall

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

Firm 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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102216XIO RTP SYSTEMComputerized Medical Systems, Inc. · 2010-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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