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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0194-2024 |
| Event ID | 93052 |
| Event Description | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 |
| Product Type | Devices |
| Distribution | US Nationwide distribution |
| Quantity | 3948 devices |
| Recall Reason | There 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 Classification | 20231115 |
| Device Code Info | Model BF-P190 UDI-DI: 4953170342110 |
| Center Classification Date | 20231109 |
| Recall Initiation Date | 20231012 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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