Drug recall
Airway Mobilescope MAF-TM
FDA recall event 80925 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 80925 |
|---|---|
| Recall numbers | Z-3283-2018, Z-3284-2018, Z-3285-2018, Z-3286-2018, Z-3287-2018, Z-3288-2018, Z-3289-2018, Z-3290-2018, Z-3291-2018, Z-3292-2018, Z-3293-2018, Z-3294-2018 and 18 more |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Airway Mobilescope MAF-TM, Bronchofibercope BF-6C240, Bronchofiberscope BF-40, Bronchofiberscope BF-P40, Bronchofiberscope BF-P60 and 25 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Initiation date | Aug 8, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | May 17, 2022 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 10–99 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: