Drug recall
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic…
FDA recall event 81981 · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Event ID | 81981 |
|---|---|
| Recall numbers | Z-0959-2019 |
| Recalling firm | Shimadzu Medical Systems Usa Com |
| Product type | Devices |
| Products | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes… |
| Initiation date | Jan 14, 2019 |
| Report date | Mar 6, 2019 |
| Termination date | Jun 7, 2024 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 3008857042 |
At a glance
- 1–9 Products in this recall
- None 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: