Olympus BF-Q180 Bronchovideoscope Recalled for Infection Risk and Regulatory Issues
Olympus is recalling BF-Q180 bronchovideoscopes because they lack 510(k) clearance and are associated with a higher rate of patient infections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (infection) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180). The recall covers all serial numbers of this device. A total of 5,813 devices were distributed worldwide, including 2,648 devices distributed throughout the U.S.A.
The recall was initiated because the BF-Q180 bronchoscope does not have a 510(k) clearance. Additionally, the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
The device is 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. The recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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