Company: Vision RT Ltd
Date of Enforcement Report 10/10/2018
Class lI:

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

Recall Number: Z-0065-2019

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

RECALLING FIRM/MANUFACTURER
Vision RT Ltd, London, UK on 8/24/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
690

DISTRIBUTION
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.

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