Drug recall
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
FDA recall event 83056 · Class II · Hitachi America, Ltd., Power Systems Division
Key facts
| Event ID | 83056 |
|---|---|
| Recall numbers | Z-1892-2019 |
| Recalling firm | Hitachi America, Ltd., Power Systems Division |
| Product type | Devices |
| Products | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems. |
| Initiation date | Apr 15, 2019 |
| Report date | Jul 3, 2019 |
| Termination date | Apr 24, 2020 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3003993895 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: