Recall Z-1587-05 ยท MRM Defibrillator, Implantable, Dual-Chamber
ela Medical Llc
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual 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 atrial and ventri
| Date | Sep 24, 2005 (initiated Jul 19, 2005) |
| Status | Terminated |
| Reason | Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. |
| Root cause | Other |
| Action | A Dear Doctor letter dated 07/20/05 was sent describing the issue and providing recommendation that physicians follow-up with patients every 3 months. Patients who have frequent episodes of ventricular fibrillation or are pacemaker dependend may require prophylactic explantation or more frequent visits. A list of affected serial numbers was provided to each physician. |
| Quantity | 392 total devices (23-model 614 & 369-model 624) |
| Distribution | Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.