Olympus Corporation of the Americas recalls 8,587 bronchovideoscope units worldwide, including 4,297 in the US and 4,290 outside. The recall centers on updated IFU language for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions for remediation.
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 III BF-1TH190 is a flexible bronchovideoscope used by trained clinicians to visualize airways and perform navigation-based procedures.
The recall addresses safety and effectiveness concerns related to updated IFU guidance for use with laser, APC and high-frequency therapy equipment.
This recall is not part of a broader industry pattern.
Hospitals and clinics must implement updated protocols and training, which may delay procedures and affect scheduling until new guidance is adopted.
Recall notices and device identifiers are available on the FDA recall page linked in the source data and Olympus communications.
4-8 weeks for refunds or replacements after submission of required documentation
Document all communications, keep copies of recall notices, UDI and model verification, and preserve receipts and shipment records for replacement devices
Model BF-1TH190; UDI 4953170434778; All Serial Numbers affected. US distribution: nationwide. International distribution: outside US. Quantity recalled: 4,297 US; 4,290 outside US. Price: Unknown.
No injuries or incidents have been reported.
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