Z-2012-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- June 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Reason for Recall
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Distribution Pattern
US Nationwide Distribution.
Code Information
All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998