Product Wiki · Recalls · U.S. FDA — Device Enforcement

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160 — recall Z-0189-2024

U.S. FDA — Device Enforcement · United States · 2023-10-12 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0189-2024
Date of alert
2023-10-12
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
4953170308185
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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