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Elekta, Inc. recalls XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam r
Recalled October 28, 2015 · FDA recall Z-0130-2016 · Elekta
Hazard
Incorrect Treatment Delivery Using Third Party Fixed Wedges. · FDA Class II
Units
1440 units
Sold at
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.
Description
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
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.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →