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Elekta, Inc. recalls Precise Digital Accelerator Delivery of radiation to defined target volumes
Recalled September 26, 2012 · FDA recall Z-2405-2012 · Elekta
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. · FDA Class II
Units
110
Sold at
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
Description
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.
Product
Precise Digital Accelerator Delivery of radiation to defined target volumes
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →