Device Recall AMS Her Option Cryoablation Therapy Disposable Probe

  • Model / Serial
    Lots 431803 & 436666
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI
  • Product Description
    her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA