Device recall
Z-2469-2018: Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is…
FDA device recall · Class II · Fx Solutions
Key facts
| Recall number (Z-number) | Z-2469-2018 |
|---|---|
| Recall event | 80302 |
| Product | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to… |
| Product code | HSD |
| Recalling firm | Fx Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2019 |
| 510(k) numbers | K111097 |
| FEI number | 3009532798 |
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