FDA-Device2018-10-10Class II
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
Vision RT Ltd
Hazard
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Sold states
Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Affected count
690 systens
Manufactured in
Dove House, Arcadia Avenue, London, United Kingdom
Products
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2019Don't want to check this manually?
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