Devices

Tachos DR - Implantable Cardioverter Defibrillator.

  • Modèle / numéro de série
    Model No. 355 572 Serial Nos. 78011361, 78011362, 78011364, 78011365, 78011376, 78011378-78011385, 78011389-78011414, 78011416-78011424, 78011426-78011430, 78011432-78011464, 78011466-78011491, 78011493-78011499, 78011600-78011617, 78011619, 78011621-78011639, 78011641, 78011643, 78011647-78011654, 78011656-78011660, 78011684-78011686, 78011689, 78011691, 78011692, 78011699-78011701, 78011704-78011708, 78011713, 78011720-78011723, 78011730-78011743, 78011745-78011758, 78011764-78011768, 78011779
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
  • Description du dispositif
    Tachos DR - Implantable Cardioverter Defibrillator.
  • Manufacturer
    Biotronik Inc
  • 1 Event

Fabricant

Biotronik Inc
  • Adresse du fabricant
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • Commentaire du fabricant
    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