Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UM160 - Produ
Recalled Product
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
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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