Drug recall
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic…
FDA recall event 87593 · Class III · Boston Scientific Corporation
Key facts
| Event ID | 87593 |
|---|---|
| Recall numbers | Z-1492-2021 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | May have been programmed with a less than optimal brightness setting resulting in a darker than desired image |
| Initiation date | Mar 16, 2021 |
| Report date | May 5, 2021 |
| Termination date | May 2, 2022 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None 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: