Recall Z-0192-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0192-2024
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: K121959. Product: EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170. 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

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

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.

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