Events

Device Recall Philips Healthcare HeartStart MRx 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
    56255
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0322-2011
  • 사례 시작날짜
    2010-07-16
  • 사례 출판 날짜
    2010-11-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93077
  • 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
    Updated instructions for use- heartstart mrx monitor/defibrillator. the update provides more detailed information on: " default ecg lead behavior " synchronized cardioversion using external paddles.
  • 조치
    Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification. For questions regarding this recall call (800) 722-9377.

Device

Device Recall Philips Healthcare HeartStart MRx
  • 모델명 / 제조번호(시리얼번호)
    This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LEBANON LIBYAN ARAB JAMAHIRI LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA SAUDI ARABIA SERBIA&MONTE; NEGRO SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA VIET NAM YEMEN
  • 제품 설명
    HeartStart MRx Defibrillator/Monitor || Models: M3535A / M3536A / M3536J / M3536MC || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • 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