Device product
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.
Z-1952-2018
Product summary
- Event
- Event 79762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6447
- Official record key
device-enforcement:Z-1952-2018
Official wording
Reason: There is a potential for the cord to spark and cause a fire.
Code information: All lots manufactured before December 7, 2017 UDI (00821925008700)
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.
Derived failure modes
-
Unknown
There is a potential for the cord to spark and cause a fire.