BF-1TH190 bronchovideoscopes recalled for clarified instructions on high frequency therapy
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-1TH190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The EVIS EXERA III Bronchovideoscope Olympus BF-1TH190 is being recalled for additional instructions-for-use updates.
The updates provide further clarification on the safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation and high-frequency therapy equipment.
The recall covers 4,297 units in the United States and 4,290 outside it, across all serial numbers, UDI 4953170434778. Distribution was nationwide in the United States. The FDA has classified the recall as Class I.
Bronchoscopy units should obtain and follow the updated instructions for use before combining these scopes with the listed energy equipment.
The recalled product
- Product
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Bronchoscope
- Hazard
- labeling-update
- instructions-for-use
- energy-device-compatibility
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-1TH190
- UDI: 4953170434778
- All Serial No.
Distribution
Distributed nationwide across the United States.
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