medical Class II Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic i

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number (UDI-DI): BF-UC180F (04953170356360), BF-UC190F (04953170399831).
View official government recall

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