Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - P
Recalled Product
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
Hazard / Issue
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Issued by
FDA
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