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Accuray Incorporated recalls CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robo
Recalled February 17, 2016 · FDA recall Z-0771-2016 · Accuray Incorporated
Hazard
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient. · FDA Class II
Units
226
Sold at
Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.
Description
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
Product
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →