Drug recall
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for…
FDA recall event 85475 · Class III · Immersivetouch Inc
Key facts
| Event ID | 85475 |
|---|---|
| Recall numbers | Z-2041-2020 |
| Recalling firm | Immersivetouch Inc |
| Product type | Devices |
| Products | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Observed an internal repetitive software glitch in ImmersiveView. |
| Initiation date | Apr 3, 2020 |
| Report date | May 27, 2020 |
| City | Chicago |
| State | IL |
| Country | United States |
| FEI number | 3014833795 |
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: