Olympus Corporation of the Americas recalled 395 units of the EVIS EXERA II Bronchovideoscope BF Type Q180-AC on September 11, 2025. The recall addresses additional instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers must stop using the device immediately.
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 recalled product is the EVIS EXERA II Bronchovideoscope, model BF-Q180-AC. The device has a Unique Device Identifier (UDI) of 4953170340086. The product was distributed nationwide in the U.S. and 165 units were distributed outside the U.S.
The recall involves updated instructions for safe and effective use of the bronchovideoscope in conjunction with laser and argon plasma coagulation, as well as high-frequency therapy equipment. Misuse of the device can lead to serious complications during procedures.
No specific incidents or injuries have been reported associated with this recall. The classification of the recall as Class I indicates a high hazard potential.
Patients and healthcare providers should immediately stop using the EVIS EXERA II Bronchovideoscope. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.
For more information, contact Olympus Corporation of the Americas at their website or through their customer service.
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