FDA Device recall Z-0065-2019
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only by Vision Rt, citing RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0065-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-24 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vision Rt |
| Distribution | US |
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
Reason
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Identifiers
| code_info | Software: Kingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial, MR1, MR2, MR3) V5.0.1749 Serial numbers:…Software: Kingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial, MR1, MR2, MR3) V5.0.1749 Serial numbers: 248-010 248-013 248-016 248-021 248-022 248-030 248-038 248-041 248-042 248-048 248-054 248-063 248-064 248-069 248-070 248-071 248-072 248-076 248-080 248-083 248-084 248-085 248-087 249-0003 249-0004 249-0005 249-0006 249-0008 249-0009 249-0010 249-0011 249-0012 249-0013 249-0014 249-0015 249-0016 249-0017 249-0018 249-0019 249-0020 249-0021 249-0022 249-0023 249-0024 249-0025 249-0026 249-0027 249-0028 249-0029 249-0030 249-0031 249-0032 249-0033 249-0034 249-0035 249-0036 249-0037 249-0043 249-0045 249-0047 249-0055 249-0056 249-0057 249-0058 249-0061 249-0069 249-0071 249-0072 249-0073 249-0074 249-0075 249-0076 249-0077 249-0078 249-0079 249-0080 249-0081 249-0082 249-0083 249-0084 249-0085 249-0086 249-0087 249-0088 249-0089 249-0090 249-0091 249-0095 249-0096 249-0097 249- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0065-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.