FDA-Device2023-09-06Class II
Visera Hysterovideoscope Olympus HYF Type V
Olympus Corporation of the Americas
Hazard
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Sold states
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.
Affected count
363 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Visera Hysterovideoscope Olympus HYF Type V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2023Don't want to check this manually?
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