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Elekta, Inc. recalls Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as
Recalled February 18, 2015 · FDA recall Z-1088-2015 · Elekta
Hazard
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail. · FDA Class II
Units
46
Sold at
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.
Description
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Product
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →