Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following recall 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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Bronchovideoscopes are used by healthcare professionals to view airways during bronchoscopy. They enable diagnosis and treatment of lung conditions.
IFU updates are to clarify safe use when paired with energy devices like lasers and argon plasma coagulation. Misuse could lead to improper operation or patient risk.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate halt in use; reliance on updated IFU to ensure safe operation in complex procedures.
FDA recall page and Olympus customer support for product identifiers and instructions
Remedy processing times vary; follow official instructions for timelines
Keep recall notice, model and UDI details, communications with manufacturer, and any updated IFU for records
Model No. BF-1TH1100. UDI: 4953170424199. All Serial No. US distribution not specified; 1,913 units in outside U.S. distribution. Sold nationwide in the U.S.; 0 units in the U.S. currently recalled.
No specific injuries or incidents are reported in the provided data.
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