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Accuray Incorporated recalls Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning
Recalled February 5, 2014 · FDA recall Z-0828-2014 · Accuray Incorporated
Hazard
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching. · FDA Class II
Units
302 devices; 149 in US, 153 out of US.
Sold at
Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam
Description
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Product
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →