Vision RT Ltd recalls Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-di…

Recall date

August 24, 2018

Source

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

Recall number

Z-0065-2019

FDA classification

Class II

Brand / firm

Vision RT Ltd

Sold / distributed

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…

Why it was recalled

RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

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

What was recalled

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