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Vision RT Ltd recalls Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-d
Recalled October 10, 2018 · FDA recall Z-0065-2019 · Vision RT
Hazard
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB · FDA Class II
Units
690 systens
Sold at
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.
Description
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Product
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
Manufacturer(s)
Vision RT Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →