Recall Z-0065-2019 ยท IYE Accelerator, Linear, Medical
Vision RT Ltd
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
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB |
| Root cause | Software design |
| 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 . |
| Quantity | 690 systens |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123371 | ALIGNRT PLUS Vision RT Limited, Jan 8, 2013 |