Drug recall
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product…
FDA recall event 85416 · Class II · Shimadzu Medical Systems
Key facts
| Event ID | 85416 |
|---|---|
| Recall numbers | Z-2591-2020 |
| Recalling firm | Shimadzu Medical Systems |
| Product type | Devices |
| Products | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The DAP meters were found to be outside of tolerance. |
| Initiation date | Nov 4, 2019 |
| Report date | Jul 22, 2020 |
| 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: