Device Recall Alto VR ICD and Alto 2 VR ICD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ela Medical Llc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    32687
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1597-05
  • 사례 시작날짜
    2005-07-19
  • 사례 출판 날짜
    2005-09-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2007-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Defibrillator, Implantable, Dual-Chamber - Product Code MRM
  • 원인
    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.
  • 조치
    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.

Device

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
  • 제품 설명
    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

Manufacturer

  • 제조사 주소
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA