PlainRecalls
FDA Devices Critical Class I Ongoing

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Reported: November 15, 2023 Initiated: October 12, 2023 #Z-0192-2024

Product Description

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

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

Units Affected
32211 devices
Distribution
US Nationwide distribution
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170. Recalled by Olympus Corporation of the Americas. Units affected: 32211 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-0192-2024.