Aizu Olympus Co., Ltd. recalls Ultrasonic gastrovideoscope-Real time ultrasound imaging,ult
Recalled Product
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
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
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