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FDAFDA · Food and drugs·Recall number Z-1197-2014

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.

Published March 19, 2014 · Recall initiated: February 17, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Elekta, Inc.
Distributor
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.
Lot
Versions 4.1 and higher
Risk classification
Class II
Area (FDA)
device
Country
United States

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