Drug recall
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The…
FDA recall event 62870 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 62870 |
|---|---|
| Recall numbers | Z-2254-2012 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from… |
| Initiation date | Jun 15, 2012 |
| Report date | Aug 29, 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
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: