Olympus Corporation of the Americas recalls 3,250 EVIS EXERA II BF-P180 Bronchovideoscopes sold in the United States and internationally. The recall updates the instructions for use to clarify safe and effective use with laser, argon plasma coagulation, and high-frequency therapy equipment. Healthcare providers should stop using the device immediately and contact Olympus for instructions.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions
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The EVIS EXERA II BF-P180 bronchovideoscope is a flexible instrument used in bronchoscopy to visualize airways. It is typically employed by trained clinicians during diagnostic and interventional procedures.
The recall targets updated Instructions for Use to ensure safe and effective operation when the bronchoscope is used with laser, argon plasma coagulation and high-frequency therapy devices. Misuse or deviation from the updated guidelines could pose risks to patients.
This recall is not stated as part of a broader industry pattern.
Clinicians must review updated guidance and pause use of affected devices until instructions are followed. The recall emphasizes preventing misuse in conjunction with adjunct equipment.
UDI 4953170339288 and model BF-P180 are on the device label; official recall notices are available through the FDA recall page linked in the article.
Not specified by the recall; healthcare providers should follow Olympus guidance and monitor updates.
Keep copies of recall notices, model UDIs, serial numbers and correspondence with Olympus; document any device usage with adjunct equipment during procedures
Model No.: BF-P180 UDI: 4953170339288 Serial numbers: All Serial No. Sold at: US nationwide distribution to hospitals and clinics; international distribution to healthcare facilities Quantity: US 1,070 units; OUS 2,180 units Price: Unknown Sold since: Unknown
No injuries or incidents have been reported.
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