Device Recall AEM Disposable Electrodes

  • Modelo / Serial
    RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
  • Descripción del producto
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. || AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA