Drug recall
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography…
FDA recall event 81080 · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Event ID | 81080 |
|---|---|
| Recall numbers | Z-0197-2019 |
| Recalling firm | Shimadzu Medical Systems Usa Com |
| Product type | Devices |
| Products | TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or… |
| Initiation date | Jun 15, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Apr 28, 2021 |
| 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: