Device recall
Z-0174-2022: Concerto User Interface Software provided with the following systems: (1)…
FDA device recall · Class II · Xstrahl Limited
Key facts
| Recall number (Z-number) | Z-0174-2022 |
|---|---|
| Recall event | 88732 |
| Product | Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy… |
| Product code | JAD |
| Recalling firm | Xstrahl Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2024 |
| 510(k) numbers | K172080, K962613 |
| FEI number | 3004561814 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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