Events

GE Healthcare Dash 3000, 4000 and 5000 patient monitors 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
    56664
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0359-2011
  • 사례 시작날짜
    2010-10-11
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94202
  • 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
    The power supply board in ge healthcare dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. insufficient solder on the power supply board could result in excess emc emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in a loss of monitoring that could delay recognition of a clinic.
  • 조치
    GE Healthcare issued an "Urgent Medical Device Correction" letter dated October 8, 2010, which described the loss of monitoring issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to remove the units from use. Local service representatives will contact firms to schedule installation of replacement power supply boards. GE Healthcare can be contacted at 1-800-558-7044, Option 2, Technical Support, about this correction.

Device

GE Healthcare Dash 3000, 4000 and 5000 patient monitors
  • 모델명 / 제조번호(시리얼번호)
    Serail Number SD010085037GA SD010085039GA SD010085040GA SD010085056GA SD010085038GA SD010085041GA SD010085054GA SD010085055GA SD010085058GA SD010085059GA SD010085060GA SD010085061GA SD010085062GA SD010085064GA SD010095296GA SD010095300GA SD010095301GA SD010095302GA SD010095303GA SD010095304GA SD010095305GA SD010095306GA SD010095307GA SD010095308GA SD010095309GA SD010095310GA SD010085197GA SD010095549GA SD010095550GA SD010095551GA SD010095552GA SD010095553GA SD010095556GA SD010095557GA SD010095558GA SD010095560GA SD010095561GA SD010095562GA SD010095563GA SD010095564GA SD010095565GA SD010095566GA SD010095569GA SD010095570GA SD010095571GA SD010095573GA SD010095574GA SD010095575GA SD010095720GA SD010095481GA SD010095482GA SD010095484GA SD010095487GA SD010095488GA SD010095619GA SD010095620GA SD010095621GA SD010095623GA SD010095399GA SD010095385GA SD010095369GA SD010095373GA SD010095408GA SD010095410GA SD010095411GA SD010095412GA SD010095413GA SD010095267GA SD010095269GA SD010095270GA SD010095271GA SD010095272GA SD010095274GA SD010095275GA SD010095384GA SD010095386GA SD010095387GA SD010095388GA SD010095389GA SD010095390GA SD010095391GA SD010095392GA SD010095393GA SD010095394GA SD010095415GA SD010095416GA SD010095417GA SD010095419GA SD010095455GA SD010095457GA SD010095458GA SD010095463GA SD010095465GA SD010095466GA SD010095468GA SD010095469GA SD010095470GA SD010095471GA SD010095472GA SD010095473GA SD010095475GA SD010095223GA SD010095225GA SD010095227GA SD010095228GA SD010095229GA SD010095230GA SD010095231GA SD010095232GA SD010095233GA SD010095234GA SD010095235GA SD010095236GA SD010095237GA SD010095239GA SD010095240GA SD010095242GA SD010095243GA SD010095244GA SD010095245GA SD010095247GA SD010095248GA SD010095249GA SD010095251GA SD010095252GA SD010095253GA SD010095259GA SD010095260GA SD010095261GA SD010095420GA SD010095421GA SD010095423GA SD010095424GA SD010095427GA SD010095428GA SD010095418GA SD010095480GA
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA in the states of IL, NV, TX, and VA, and the countries of Australia, Brazil, China, Japan, South Korea, and Taiwan.
  • 제품 설명
    Power supply boards on Dash 3000, 4000 and 5000 Monitors. || GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • 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