Recall Z-3017-2020— Olympus Corporation of the Americas

Name: FDA recall Z-3017-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-08-31, terminated 2024-02-14. It names one FDA 510(k) clearance: K061313. Product: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.. Reason: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Terminated: 2024-02-14
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K061313 — EVIS EXERA 180 SYSTEMOlympus Medical Systems Corporation·cleared 2006-08-31

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

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Reason for recall

The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.

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