Device recall
Z-1838-2015: PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with…
FDA device recall · Class II · Hitachi America, Ltd., Power Systems Division
Key facts
| Recall number (Z-number) | Z-1838-2015 |
|---|---|
| Recall event | 71056 |
| Product | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. |
| Product code | LHN |
| Recalling firm | Hitachi America, Ltd., Power Systems Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2016 |
| 510(k) numbers | K073059 |
| 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