Drug recall
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be…
FDA recall event 80067 · Class II · Shimadzu Medical Systems
Key facts
| Event ID | 80067 |
|---|---|
| Recall numbers | Z-2060-2018 |
| Recalling firm | Shimadzu Medical Systems |
| Product type | Devices |
| Products | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time"… |
| Initiation date | Jan 12, 2018 |
| Report date | Jun 20, 2018 |
| Termination date | Feb 24, 2022 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 1000125362 |
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: