Olympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures
Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.
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: This is an FDA Class I medical device recall, which requires a minimum severity score of 4 per the rubric. The hazard—endobronchial combustion during therapeutic laser procedures—creates a direct fire and burn risk during invasive medical procedures, though no patient injuries or deaths are documented in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2 and BF-TE2. These are diagnostic bronchoscopes used by physicians to visualize the airways during medical procedures.
The FDA has classified this as a Class I recall due to complaints of endobronchial combustion—fire or burning within the airway—occurring during therapeutic laser procedures using these devices. Combustion during a medical procedure poses a serious risk of harm to patients.
This recall affects 4 units distributed nationwide in the United States. Healthcare facilities and providers should identify any affected devices and cease using them for laser-assisted procedures until further instruction.
Patients or providers who have questions about this recall should contact Olympus Corporation of the Americas. The FDA has assigned this recall the number Z-2012-2023 for reference.
The recalled product
- Product
- Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- fire
- burn-injury
Distribution
Distributed nationwide across the United States.
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