Device recall
Z-3125-2024: Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software…
FDA device recall · Class II · Hitachi America, Ltd., Particle Therapy Division
Key facts
| Recall number (Z-number) | Z-3125-2024 |
|---|---|
| Recall event | 94928 |
| Product | Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose… |
| Product code | LHN |
| Recalling firm | Hitachi America, Ltd., Particle Therapy Division |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232032 |
| FEI number | 3003993895 |
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