Accuray Incorporated recalls CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic…

Recall date

January 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0771-2016

FDA classification

Class II

Brand / firm

Accuray Incorporated

Sold / distributed

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 Belgi…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.