Olympus Corporation recalled 619 bronchoscope units on September 11, 2025. The recall affects the EVIS EXERA b BRONCHOVIDEOSCOPE BF-XT190 due to additional instructions for safe use. Healthcare providers and patients 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 recall involves the EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190. A total of 361 units were distributed in the United States, while 258 units were distributed outside the U.S. The device is part of the medical equipment range.
The recall addresses the need for updated instructions for use (IFU) to clarify the effective use of bronchoscope models when paired with laser and high-frequency therapy equipment. This clarification aims to prevent potential misuse and ensure patient safety.
There are no reported incidents or injuries directly linked to this recall. However, the high-risk classification indicates that improper usage could lead to serious complications.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by Olympus Corporation of the Americas.
For further instructions, contact Olympus Corporation of the Americas at [insert phone number]. Visit their website for more details.
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