Sterile packaging containing 01 Cardioversor Implantable Defibrillator Belos VR (VVIRD) and accessories: wrench, silicone glue, mineral oil.

제조사

  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    ANVSANVISA