Olympus BF-Q170 Bronchoscope Instruction Clarification For Therapeutic Equipment Use
Instruction clarifications have been issued for the Olympus BF-Q170 bronchoscope regarding safe and effective use with laser, argon plasma, and high-frequency therapeutic equipment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall, which automatically requires a minimum severity score of 4 per the rubric. No illnesses or injuries are reported. The recall involves clarification of instructions for safe and effective use with therapeutic equipment.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Olympus BF-Q170 bronchovideoscope. The recall affects one unit distributed in the United States and 2,306 units distributed outside the United States.
Additional clarifications have been issued in the device's Instructions for Use (IFU) to address safe and effective use when the bronchoscope is operated in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Healthcare facilities and practitioners using the Olympus BF-Q170 should obtain and review the updated Instructions for Use. Olympus Corporation of the Americas is the manufacturer and is responsible for implementing this recall. Consult the FDA or manufacturer for complete updated guidance.
The recalled product
- Product
- BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- equipment-interaction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. BF-Q170
- UDI: 4953170342912
- All Serial No.
Distribution
Distributed nationwide across the United States.
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