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Elekta, Inc. recalls SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics d
Recalled March 26, 2014 · FDA recall Z-1064-2014 · Elekta
Hazard
Customers are resetting the default values outside recommended factory settings. · FDA Class II
Units
449
Sold at
Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Description
Customers are resetting the default values outside recommended factory settings.
Product
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →