Reported Oct 7, 2020 · Terminated
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180)
- All serial numbers - Product Usagedesigned 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
- Lot codes and dates
- All serial numbers
- Amount recalled
- 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Olympus Corporation of the Americas recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.