Drug recall
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile…
FDA recall event 78569 · Class II · Volcano Corporation
Key facts
| Event ID | 78569 |
|---|---|
| Recall numbers | Z-0189-2018 |
| Recalling firm | Volcano Corporation |
| Product type | Devices |
| Products | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device. |
| Initiation date | Nov 3, 2017 |
| Report date | Dec 6, 2017 |
| Termination date | Oct 20, 2023 |
| City | Rancho Cordova |
| State | CA |
| Country | United States |
| FEI number | 2939520 |
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: