FDA-Device2014-11-05Class II
Laksell Gamma Knife Perfexion
Elekta, Inc.
Hazard
Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.
Sold states
Worldwide Distribution - USA (nationwide) including the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OR, PA, RI, SC, TX, TN, UT, VA, WA and WV, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Mexico, Morocco, Netherland, Norway, Poland, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Affected count
181
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Laksell Gamma Knife Perfexion
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2015Don't want to check this manually?
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