FDA-Device2018-10-10Class II
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Varian Medical Systems
Hazard
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Sold states
Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom
Affected count
4
Manufactured in
3100 Hansen Way, Palo Alto, CA, United States
Products
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0005-2019Don't want to check this manually?
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