Z-1292-2021 Class II Terminated
FDA device recall Z-1292-2021 was initiated by Olympus Corporation of the Americas on January 28, 2021 and is designated Class II. Reason for recall: 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- 2… The recall status is terminated (terminated March 13, 2024). Affected quantity: 1564 devices total (Domestic: 627 devices, Foreign: 937 devices).
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- January 28, 2021
- Termination Date
- March 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1564 devices total (Domestic: 627 devices, Foreign: 937 devices)
Product Description
Reason for Recall
Distribution Pattern
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.