Drug recall
Hitachi Scenaria Whole-body X-ray CT System
FDA recall event 84133 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 84133 |
|---|---|
| Recall numbers | Z-0271-2020 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | Hitachi Scenaria Whole-body X-ray CT System |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. |
| Initiation date | Oct 16, 2019 |
| Report date | Nov 13, 2019 |
| Termination date | Apr 30, 2020 |
| 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: