Olympus recalls all Evis Exera II Bronchovideoscopes (BF-Q180) due to higher patient infection rates compared to other OMSC models. No 510(k) clearance was issued for this device.
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.
Olympus is recalling all Evis Exera II Bronchovideoscopes (BF-Q180) because they lack 510(k) clearance and have been linked to higher infection rates than other Olympus bronchoscopes. This affects medical professionals using the device during procedures.
The BF-Q180 bronchoscope lacks 510(k) clearance, meaning it was not approved by the FDA for medical use. This device has been associated with a higher rate of patient infections compared to other Olympus bronchoscopes.
Medical professionals who use the Olympus Evis Exera II Bronchovideoscope (BF-Q180) during procedures are affected. Patients undergoing endoscopic procedures with this device are at slightly higher risk of infection.
Check for the model name 'Olympus BF Type Q180 (BF-Q180)' on the device. All serial numbers are affected by this recall.
Identify the model name and serial number to confirm if your device is affected.
The device lacks 510(k) clearance and has been associated with higher infection rates than other Olympus bronchoscopes, so it is not approved for medical use.
Look for the model name 'Olympus BF Type Q180 (BF-Q180)' and any serial number on the device.
The recall does not specify a remedy, so contact Olympus for guidance on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-3017-2020 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-3017-2020 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
