Drug recall
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and…
FDA recall event 73612 · Class II · Optovue, Inc.
Key facts
| Event ID | 73612 |
|---|---|
| Recall numbers | Z-1498-2016 |
| Recalling firm | Optovue, Inc. |
| Product type | Devices |
| Products | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map. |
| Initiation date | Mar 16, 2016 |
| Report date | Apr 27, 2016 |
| Termination date | Apr 4, 2017 |
| 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: