Events

Device Recall LIFEPAK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Physio Control Corp 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
    29025
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1107-04
  • 사례 시작날짜
    2004-05-05
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-05-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32993
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • 원인
    Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ecg monitoring, external pacing or defibrillation; ecg connector with higher than normal connection resistance resulting in intermittent ecg signal; therapy connector has potential for impact damage.
  • 조치
    The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices.

Device

Device Recall LIFEPAK
  • 모델명 / 제조번호(시리얼번호)
    Non-continuous Serial Numbers between 1178083 and 305080962.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.
  • 제품 설명
    LIFEPAK 12 defibrillator/monitor || Part Numbers: || VLP12-02-000000 through VLP12-02-005003, || AVLP12-02-000000 through AVLP12-02-005003, || DVLP12-02-000000 through DVLP12-02-005003, || EVLP12-02-000000 through EVLP12-02-005003, || FVLP12-02-000000 through FVLP12-02-005003, || LVLP12-02-000000 through LVLP12-02-005003, || PVLP12-02-000000 through PVLP12-02-005003, || UVLP12-02-000000 through UVLP12-02-005003
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • 제조사 주소
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA