Drug recall
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging…
FDA recall event 71431 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 71431 |
|---|---|
| Recall numbers | Z-2366-2015 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. |
| Initiation date | Apr 25, 2014 |
| Report date | Aug 19, 2015 |
| Termination date | Aug 24, 2018 |
| 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: