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Olympus Corporation of the Americas Recall 93052

Description: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

Olympus Corporation of the Americas Recall 93052 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0194-2024
Event ID93052
Event DescriptionEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Product TypeDevices
DistributionUS Nationwide distribution
Quantity3948 devices
Recall ReasonThere is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
Device Classification20231115
Device Code InfoModel BF-P190 UDI-DI: 4953170342110
Center Classification Date20231109
Recall Initiation Date20231012
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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