Z-2480-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

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