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Accuray Incorporated recalls Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Recalled September 6, 2023 · FDA recall Z-2489-2023 · Accuray Incorporated
Hazard
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel. · FDA Class II
Units
82
Sold at
Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Description
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
Product
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →