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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