Olympus Corporation of the Americas Recall 92362
Description: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Olympus Corporation of the Americas Recall 92362 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2012-2023 |
Event ID | 92362 |
Event Description | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 |
Product Type | Devices |
Distribution | US Nationwide Distribution. |
Quantity | 4 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-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998 |
Center Classification Date | 20230717 |
Recall Initiation Date | 20230608 |
Recalling Firm | Olympus Corporation of the Americas |
Initial Notification | Letter |
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