Events

Device Recall HeartStart FR2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    37477
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0641-2007
  • 사례 시작날짜
    2007-02-28
  • 사례 출판 날짜
    2007-03-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50603
  • 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 Defibrillator - Product Code MKJ
  • 원인
    Failure of tactile switches on one of two printed circuit board assemblies (pcba) used in the fr2+ device. potential delay or prevention of shock treatment due to pcba board contamination, causing intermittent switch operation.
  • 조치
    On 02/28/2007 the firm sent letters via return receipt to all domestic and foreign customers. The letter advises the customer of the issue and if the user encounters the problem, to press the button again with additional force. In addition, the firm sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock' buttons firmly.

Device

Device Recall HeartStart FR2
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.
  • 제품 설명
    Philips HeartStart FR2+ Defibrillator || Automated External Defibrillator (AED) || Catalog Numbers: M3860A/M3861A/M3840A/M3841A
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA