Drug recall
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes…
FDA recall event 62372 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 62372 |
|---|---|
| Recall numbers | Z-2037-2012 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued… |
| Initiation date | May 4, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Feb 19, 2013 |
| City | Twinsburg |
| State | OH |
| Country | United States |
| FEI number | 1528028 |
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: