Olympus Medical Systems Corporation recall
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed…
Why was Olympus Medical Systems Corporation 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
- Distribution
- Worldwide distribution - US Nationwide and International.
- Recall date
- October 7, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)