Events

Device Recall Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    63654
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0813-2013
  • 사례 시작날짜
    2012-06-13
  • 사례 출판 날짜
    2013-02-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114419
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Ge has become aware of multiple issues affecting the dash 3000/4000/5000 patient monitor. these issues may occur when the ethernet controller in the xpc823 cpu on the dash and dashport 2 motherboard functions intermittently. ge healthcare has identified that these issues occur most often at sites with large unity network installations. it should be noted that the dash 3000/4000/5000 patient m.
  • 조치
    GE Healthcare sent an Important Product Information letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told the otherboard would be replaced, on request, should the customer continue to expeience the issue with the affected product. A second letter dated August 30, 2012, was sent on September 5, 2012, informing consignees that the motherboard replacement did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided when it is available. Customers with questions were instructed to call 1-800-558-7044. For questions regarding this recall call 262-513-4122.

Device

Device Recall Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories.
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT. ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM, URUGUAY. PUERTO RICO
  • 제품 설명
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA