Device recall
Z-0389-2022: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray…
FDA device recall · Class II · Xstrahl Limited
Key facts
| Recall number (Z-number) | Z-0389-2022 |
|---|---|
| Recall event | 88545 |
| Product | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system |
| Product code | JAD |
| Recalling firm | Xstrahl Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2026 |
| 510(k) numbers | 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