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Olympus Corporation of the Americas recalls Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, do
Recalled March 31, 2021 · FDA recall Z-1292-2021 · Olympus Corporation of the Americas
Hazard
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315). · FDA Class II
Units
1564 devices total (Domestic: 627 devices, Foreign: 937 devices)
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Japan, Europe, Australia.
Description
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
Product
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →