Recall Z-1952-2018 ยท FAS Electrode, Electrosurgical, Active, Urological
Gyrus Acmi, Incorporated
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,
| Date | Apr 17, 2018 |
| Status | Terminated |
| Reason | There is a potential for the cord to spark and cause a fire. |
| Root cause | Device Design |
| Action | Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on |
| Quantity | 6447 |
| Distribution | 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 : |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890328 | ADULT RESECTOSCOPE Circon Video, Feb 6, 1990 |