Aizu Olympus Co., Ltd.: Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surroun

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: 5 units Lot/code info: Model Number (UDI-DI): TGF-UC180J (04953170328480).

UPC codes

04953170328480

Source

Official record: FDA (Device enforcement) ↗

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