Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Prod
Recalled Product
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.
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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