Recall Z-0189-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0189-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-12

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-10-12. It names one FDA 510(k) clearance: K023984. Product: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160. 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2023-10-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co.·cleared 2003-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.