Events

Device Recall Phiips Healthcare HeartStart MRx/MRxE Defibrillator/Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    52575
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1795-2009
  • 사례 시작날짜
    2009-07-07
  • 사례 출판 날짜
    2009-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83387
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Automated external defibrillators (non-wearable) - Product Code mkj
  • 원인
    External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/cpr cable and the mrx/mrxe may wear at an increased rate ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected.
  • 조치
    Philips Healthcare issued an "Urgent - Voluntary Medical Device Correction" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service. Contact Philips Healthcare for further questions at 1-800-722-9377.

Device

Device Recall Phiips Healthcare HeartStart MRx/MRxE Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libyan Arab Jamaica, Lithuania, Netherlands, New Caldonia, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • 제품 설명
    HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only. || The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA