Olympus Corporation of the Americas recalled 1,473 US units and 3,774 non-US units of the EVIS EXERA II bronchovideoscope BF-1T180. The recall concerns updated instructions for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer 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 bronchovideoscope is a flexible endoscope used to visualize the airways during bronchoscopy. It aids diagnosis and treatment planning in respiratory conditions.
The recall cites updates to the instruction for use to clarify safe use when the device is used with laser, APC, and high-frequency therapy equipment. Misinterpretation or improper use could endanger patients during procedures.
This recall is not part of a broader industry pattern.
Hospitals and clinics must review updated IFU guidance and retrain staff on safe integration with adjunct devices. No injuries have been reported in the notice, but the risk is elevated if instructions are not followed.
IFU update notices and device labeling; manufacturer website and recall notices
Timeline for remediation not specified in the recall
Retain recall notice, model and UDI information, serial numbers, dates of recall-related actions, and correspondence with Olympus.
Model No.: BF-1T180 UDI: 4953170339325 Serial numbers: All serial numbers Quantity: 1,473 US units; 3,774 units outside the US Sold in: US nationwide distribution Sold From: Unknown Price: Unknown
No injuries or incidents have been reported.
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