Device recall
Z-0065-2019: Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant…
FDA device recall · Class II · Vision RT Ltd
Key facts
| Recall number (Z-number) | Z-0065-2019 |
|---|---|
| Recall event | 81089 |
| 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 |
| Product code | IYE |
| Recalling firm | Vision RT Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2022 |
| 510(k) numbers | K123371 |
| FEI number | 3004832819 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database