PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 7, 2020 Initiated: August 31, 2020 #Z-3017-2020

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.

Details

Units Affected
5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
Distribution
Worldwide distribution - US Nationwide and International.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3017-2020.

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