FDA-Device2016-02-10Class II
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Olympus Corporation of the Americas
Hazard
Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
Sold states
US Nationwide Distribution except PR
Affected count
4436
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0757-2016Don't want to check this manually?
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