Device Recall Philips Medical HeartStart MRx 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
    54892
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1317-2010
  • 사례 시작날짜
    2010-03-04
  • 사례 출판 날짜
    2010-04-09
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-02-15
  • 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
    Defibrillator Monitor - Product Code MKJ
  • 원인
    Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.
  • 조치
    An "Urgent Medical Device Correction" letter with a Field Safety Notice was issued on March 4, 2010 to affected customers. The Instructions for Use Addendum/Application Note is included with the communication describing when to replace the unit's 14.8-Volt Lithium Ion Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please contact your local Philips representative.

Device

  • 모델명 / 제조번호(시리얼번호)
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    No
  • 유통
    Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA;, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALAU, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, 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, VIETNAM and YEMEN.
  • 제품 설명
    HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). || 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

Manufacturer

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