Recall – Cl II Integrated Gate Controller PCB

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.

___________________________________

“Being Agile & Compliant”

2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019

Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!

Hurry to get latest discounts … submit form below:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.