Drug recall
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All…
FDA recall event 86384 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 86384 |
|---|---|
| Recall numbers | Z-3017-2020 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes. |
| Initiation date | Aug 31, 2020 |
| Report date | Oct 7, 2020 |
| Termination date | Feb 14, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 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: