Device Recall AEM Disposable Electrodes

  • Modèle / numéro de série
    RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Société-mère du fabricant (2017)
  • Source
    USFDA