Olympus recalled 262 units of the BF-XT160 bronchoscope after concerns regarding its safe use with laser and high-frequency therapy equipment. Additional instructions for use (IFU) updates clarify potential hazards. Healthcare providers and patients must cease use immediately and follow the manufacturer's 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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The Olympus BF-XT160 is a bronchoscope used in medical procedures to examine the airways and lungs. Medical professionals rely on it for diagnosing conditions and performing therapeutic interventions during bronchoscopies.
This bronchoscope presents risks when used with certain therapies such as laser or high-frequency energy. Additional instructions highlight safe practices to prevent dangerous situations during medical procedures.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients who rely on this bronchoscope for medical care, presenting potential safety hazards if not addressed promptly.
Model numbers and UDI codes are typically found on the bronchoscope's handle or packaging labels.
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements after submission.
Keep records of the recall notice, correspondence with Olympus, and any doctor visits related to the bronchoscope's use.
Brand: Olympus Corporation of the Americas Model: BF-XT160 UDI: 4953170340147 Quantity: 262 units in the US, 558 units OUS Distribution: US Nationwide Distribution
No injuries or incidents have been reported.
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