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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2017-2023
Event ID92362
Event DescriptionOlympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Product TypeDevices
DistributionUS Nationwide Distribution.
Quantity9,684 units
Recall ReasonThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Device Classification20230726
Device Code InfoAll 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 Date20230717
Recall Initiation Date20230608
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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