Home / Recalls / Olympus Corporation of the Americas / Z-3017-2020

Z-3017-2020 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 7, 2020
Initiation Date
August 31, 2020
Termination Date
February 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.

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.

Distribution Pattern

Worldwide distribution - US Nationwide and International.

Code Information

All serial numbers

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