Device Recall Alto MSP ICD and Alto 2 MSP ICD

  • Modèle / numéro de série
    devices manufactured between April 2003 and August 2004. Model 617 serial numbers: 241XH059, 305XH005 and 305XH014.   Model 627 serial numbers: 330YA541, 348YA563, 348YA571,  348YA573, 348YA576, 350YA594, 407YA604, 407YA630,  407YA635, 407YA644, 411YA001, 411YA002, 411YA011,  411YA014, 411YA015, 411YA016 and 418YA029.
  • 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 MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular 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 atrial and 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