Device Recall Platinium DR DF4 1540

  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, || Biventricular or ventricular antitachycardia pacing, || Dual or single chamber arrhythmia detection || Product Usage: || PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Manufacturer Parent Company (2017)
  • Source
    USFDA