FDA-Device2020-12-09Class II
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
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.
Sold states
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
Affected count
299 devices
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2021More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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