Device Recall Alto VR ICD and Alto 2 VR ICD

  • Modèle / numéro de série
    devices manufactured between April 2003 and August 2004. Model 615 serial number: 237XG065.   Model 625 serial numbers: 243XI009, 243XI060, 243XI075, 243XI089, 246XI019, 246XI031, 246XI076, 249XI044, 249XI045,  249XI093, 249XI106, 249XI123, 249XI134, 304XI069,  304XI070, 304XI087, 304XI095, 304XI117, 307XI016,  307XI040, 307XI041, 307XI050, 307XI053, 307XI093, 307XJ016, 312XI007, 312XI009, 312XI016, 312XI033, 312XI033, 312XI041, 312XI095, 312XI097, 312XI124, 402XI027, 402XI070, 404XI007, 404XI010, 404XI028, 404XI029, 404XI031, 404XI044, 409XI001, 409XI007,  409XI013, 409XI015, 409XI018, 413XI004, 414XI017 and 415XI025.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
  • Description du dispositif
    Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA