Device product
Visera Hysterovideoscope Olympus HYF Type V
Z-2480-2023
Product summary
- Event
- Event 92783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 363 units
- Official record key
device-enforcement:Z-2480-2023
Official wording
Reason: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Code information: Model HYF-V, all serial numbers
Distribution pattern: 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.
Derived failure modes
-
Unknown
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.