FDA-Device2012-09-26Class II
Precise Digital Accelerator Delivery of radiation to defined target volumes
Elekta, Inc.
Hazard
There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Sold states
Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto
Affected count
110
Manufactured in
4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, United States
Products
Precise Digital Accelerator Delivery of radiation to defined target volumes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2012Don't want to check this manually?
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