Drug recall
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital…
FDA recall event 77776 · Class II · Optovue, Inc.
Key facts
| Event ID | 77776 |
|---|---|
| Recall numbers | Z-0008-2018, Z-0009-2018, Z-0010-2018 |
| Recalling firm | Optovue, Inc. |
| Product type | Devices |
| Products | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the…, iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement…, iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Initiation date | Jul 27, 2017 |
| Report date | Sep 6, 2017 |
| Termination date | Apr 12, 2021 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3005950902 |
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: