Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number :GF-UM20 - Produc
Recalled Product
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
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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