FDA Enforcement
Class II
Ongoing
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
Recall: Z-0328-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0328-2024
- Event ID
- 93222
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aizu Olympus Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 17, 2023
- Address
- 3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, N/A, Japan
Description
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
Reason
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Code Info
Model Number (UDI-DI): BF-UC180F (04953170356360), BF-UC190F (04953170399831).
Distribution
Worldwide - US Nationwide distribution.
Quantity
823 units