Olympus Corporation of the Americas Recall 92362
Description: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Olympus Corporation of the Americas Recall 92362 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2017-2023 |
| Event ID | 92362 |
| Event Description | Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution. |
| Quantity | 9,684 units |
| Recall Reason | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Device Classification | 20230726 |
| Device Code Info | All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778 |
| Center Classification Date | 20230717 |
| Recall Initiation Date | 20230608 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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