FDA-Device2015-02-18Class II
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Elekta, Inc.
Hazard
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Sold states
Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.
Affected count
46
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1088-2015Don't want to check this manually?
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