Device Recall EP4 Stimulator

  • Modelo / Serial
    Systems Part Numbers: EP-4I-2-110; EP-4I-2-220; EP-4I-4-110; EP-4-220: WM-01M-241; WM-01M-560; WM-01M-1200; WM-02M-241; WM-02M-560; and WM-02M-1200.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; || EP MedSystems, Inc. || 575 Route 73 North, Units D, West Berlin, NJ 08091. || Indicated for use during clinical electrophysiology procedures.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    St. Jude Medical, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source