Olympus recalled 3,216 BF-1T60 bronchofiberscopes distributed nationwide and internationally after updating instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. The recall updates guidance to reduce risk during advanced energy-device procedures. Clinicians and facilities should stop using the devices and follow manufacturer instructions for recall.
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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Bronchoscopes are used by clinicians to view and treat the airways. The BF-1T60 is used in bronchoscopic procedures often with adjunct energy devices.
The updated IFU provides guidance on safe and effective use when the device is used with laser, APC, and high-frequency therapy equipment. Misuse could lead to patient harm.
This recall is not described as part of a broader industry pattern in the notice.
Clinicians must verify procedures and ensure adherence to the updated IFU to mitigate patient risk during energy-device-assisted bronchoscopies.
Manufacturer recall notices and the FDA enforcement page; device labeling and IFU updates from Olympus.
Refunds or replacements, if offered, may take weeks to months depending on the program.
Keep copies of recall notices, correspondence with the manufacturer, and any inventory adjustments.
Model No. BF-1T60 UDI: 4953170339264 Serial numbers: All Serial No. Sold in: US Nationwide; International distribution Sold from: Unknown Price: Unknown
No injuries or incidents have been reported.
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