Device recall
Z-2667-2016: AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated…
FDA device recall · Class II · Vision RT Ltd
Key facts
| Recall number (Z-number) | Z-2667-2016 |
|---|---|
| Recall event | 74607 |
| Product | AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. |
| Product code | IYE |
| Recalling firm | Vision RT Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2017 |
| 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