Aizu Olympus Co., Ltd.: Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tr

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide - US Nationwide distribution. Quantity: 823 units Lot/code info: Model Number (UDI-DI): BF-UC180F (04953170356360), BF-UC190F (04953170399831).

UPC codes

04953170356360, 04953170399831

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.