Vermed, Inc Radiotransparent Defibrillation Electrodes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Heart Sync, Inc 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
    65085
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1435-2013
  • 사례 시작날짜
    2013-04-26
  • 사례 출판 날짜
    2013-05-30
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-16
  • 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
    Electrode, pacemaker, temporary - Product Code LDF
  • 원인
    On 4/18/13 heartsync became aware of a recall from their wire/connector sub-assembly supplier which is used in the c100-physio electrodes. there were reports of equipment damage due to misalignment from tooling installed in august 2012. the result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
  • 조치
    HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
  • 제품 설명
    Vermed, Inc Radiotransparent Defibrillation Electrodes || Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. || Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA