FDA Recall Terminated

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: Z-0065-2019 · Initiated August 24, 2018

Recall

Recall Number
Z-0065-2019
Event Number
81089
Firm
Vision RT Ltd Dove House Arcadia Avenue London United Kingdom
FEI Number
3004832819
Product Code
IYE
Status
Terminated
Root Cause
Software design
Initiated
August 24, 2018
Terminated
July 8, 2022

Description

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

Reason

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

Action

Vision RT notified customers with Customer Information Bulletin dated August 24, 2018 to make them aware of the issue, how to spot it (in the unlikely event that it occurs) and how to deal with it. The customer contact also indicates that the issue is to be fixed with a firmware update and that this can be delivered remotely or installed on site by a service engineer,or transmit the firmware update to those customers whose systems can be accessed .

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.

Quantity

690 systens