Z-0189-2024 Class I Ongoing
FDA device recall Z-0189-2024 was initiated by Olympus Corporation of the Americas on October 12, 2023 and is designated Class I. Reason for recall: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the dist… The recall status is ongoing. Affected quantity: 15942 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- October 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15942 devices
Product Description
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Reason for Recall
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
Distribution Pattern
US Nationwide distribution
Code Information
Model BF-1T150 UDI-DI: 4953170308185; Model BF-1T60 UDI-DI: 4953170339264; Model BF-P150 UDI-DI: N/A; Model BF-P60 UDI-DI: 4953170339196; Model BF-XT160 UDI-DI: N/A