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Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center,
Recalled December 9, 2020 · FDA recall Z-0502-2021 · Olympus Corporation of the Americas
Hazard
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. · FDA Class II
Units
373 devices
Sold at
Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices
Description
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.
Product
Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →