Devices

Belos DRT

  • Model / Serial
    Serial Numbers: 79640026, 79640028, 79640030, 79640031, 79640032, 79640033, 79640035, 79640037, 79640039, 79640044, 79640048, 79640049, 79640053, 79640058, 79640060, 79640062, 79640064, 79640065, 79640070, 79640078, 79640079, 79640080, 79640081, 79640082, 79640085, 79640086, 79640087, 79640088, 79640089, 79640091, 79640093, 79640094, 79640095, 79640097, 79640104, 79640116, 79640117, 79640121, 79640239, 79640247, 79640252, 79640323, 79640324.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The firm distributes to physicians located throughout the US.
  • Product Description
    Belos DR-T Implantable Cardioverter Defibrillator
  • Manufacturer
    Biotronik Inc
  • 1 Event

Manufacturer

Biotronik Inc
  • Manufacturer Address
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • Manufacturer comment
    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
    USFDA