Olympus Corporation of the Americas recalled the BF-1TH1100 bronchoscope on September 11, 2025. The recall addresses safety concerns regarding the use of the device with certain laser therapy equipment. Healthcare providers and patients must stop using this device immediately to ensure safety.
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 Olympus Bronchoscope, Model No. BF-1TH1100. The device is classified as a Class I medical device. Although 0 units were recalled in the U.S., 1,913 units were distributed outside the U.S.
The recall involves additional instructions for use (IFU) to clarify safe practices when using the bronchoscope with laser, argon plasma coagulation, and high-frequency therapy equipment. The hazard level is classified as high due to potential risks associated with improper usage.
No specific incidents or injuries have been reported in connection with this recall. The recall is proactive to avoid potential hazards.
Stop using the bronchoscope immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and guidance on the recall.
For further information, contact Olympus Corporation of the Americas at their official website or through the recall link provided.
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