Device recall
Z-1430-2026: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
FDA device recall · Class II · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Key facts
| Recall number (Z-number) | Z-1430-2026 |
|---|---|
| Recall event | 98330 |
| Product | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR |
| Product code | LHN |
| Recalling firm | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191801, K201042 |
| FEI number | 1000162206 |
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