Device recall
Z-1892-2019: PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
FDA device recall · Class II · Hitachi America, Ltd., Power Systems Division
Key facts
| Recall number (Z-number) | Z-1892-2019 |
|---|---|
| Recall event | 83056 |
| Product | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. |
| Product code | LHN |
| Recalling firm | Hitachi America, Ltd., Power Systems Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| 510(k) numbers | K151132, K152592 |
| 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