EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Reported: November 15, 2023 Initiated: October 12, 2023 #Z-0194-2024
Product Description
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Reason for Recall
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 3948 devices
- Distribution
- US Nationwide distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190. Recalled by Olympus Corporation of the Americas. Units affected: 3948 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Critical. Recall number: Z-0194-2024.
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