Recall Z-2017-2023— Olympus Corporation of the Americas

Name: FDA recall Z-2017-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-08

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-06-08. It names 2 FDA 510(k) clearances: K183419, K121959. Product: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190. Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2023-06-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.·cleared 2019-09-05
K121959 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.·cleared 2013-01-10

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

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Reason for recall

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

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