Z-2480-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 363 units
Product Description
Visera Hysterovideoscope Olympus HYF Type V
Reason for Recall
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
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.
Code Information
Model HYF-V, all serial numbers