Events

Device Recall Central Station Monitoring System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems Information Tecnology 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
    52002
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1600-2009
  • 사례 시작날짜
    2009-03-10
  • 사례 출판 날짜
    2009-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81860
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • 원인
    Ge healthcare has become aware of a potential issue associated with the failure to restart carescape cic pro v5.1 on the mp100 hardware. this issue may impact patient safety.
  • 조치
    A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by GE Field Service team members. For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.

Device

Device Recall Central Station Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  SDY09050521GA SDY08400072GA SDY09030450GA SDY09030451GA SDY09020430GA SDY09030443GA SDY09010397GA SDY09020426GA SDY09010400GA SDY09050487GA SDY08510300GA SDY09010389GA SDY09010391GA SDY09030460GA SDY09020427GA SDY08520371GA SDY09010382GA SDY09010383GA SDY09020403GA SDY09020419GA SDY09030462GA SDY09050474GA SDY09020412GA SDY08520366GA SDY09010388GA SDY09030435GA SDY08410079GA SDY08420083GA SDY09020416GA SDY09010384GA SDY08520367GA SDY09030459GA SDY08400067GA SDY09030437GA SDY09030442GA SDY09030448GA SDY09030453GA SDY09020408GA SDY09020409GA SDY09020423GA SDY09030433GA SDY09010385GA SDY08490149GA SDY08500162GA SDY08500181GA SDY08500214GA SDY08500215GA SDY08500239GA SDY08510243GA SDY08510249GA SDY08510257GA SDY08490120GA SDY08490130GA SDY08500175GA SDY08500224GA SDY08490100GA SDY08500194GA SDY08490102GA SDY08510258GA SDY08510260GA SDY08510263GA SDY08510267GA SDY08520323GA SDY08500184GA SDY08500192GA SDY08500200GA SDY09020422GA SDY08510293GA SDY08480089GA SDY09030434GA SDY09030445GA SDY08480091GA SDY08490139GA SDY08510318GA SDY08490098GA SDY08490103GA SDY08490109GA SDY08490111GA SDY08490116GA SDY08490124GA SDY08490125GA SDY08490131GA SDY08490142GA SDY08500160GA SDY08500161GA SDY08500164GA SDY08500165GA SDY08500166GA SDY08500167GA SDY08500168GA SDY08500176GA SDY08500180GA SDY08500195GA SDY08500197GA SDY08510259GA SDY09010381GA SDY09010402GA SDY09020425GA SDY08520333GA SDY08520359GA SDY08520361GA SDY08520374GA SDY09010399GA SDY09020405GA SDY09020415GA SDY09020406GA SDY08500204GA SDY08500222GA SDY08500223GA SDY08510285GA SDY08510287GA SDY08510292GA SDY08520322GA SDY09030440GA SDY08500238GA SDY08520349GA SDY08520356GA SDY08520363GA SDY08520364GA SDY08520365GA SDY08520372GA SDY09020421GA SDY09030444GA SDY09030449GA SDY08400059GA SDY08400069GA SDY08520320GA SDY08520321GA SDY08520326GA SDY08520350GA SDY08520358GA SDY08520362GA SDY08520376GA SDY09030446GA SDY09030452GA SDY08510261GA SDY08510270GA SDY08520352GA SDY08490121GA SDY08490128GA SDY08490133GA SDY08500159GA SDY08500174GA SDY08520331GA SDY08490101GA SDY08490119GA SDY08490127GA SDY08490132GA SDY08490137GA SDY08500152GA SDY08510262GA SDY08510269GA SDY09030465GA SDY08510290GA SDY08510299GA SDY08520327GA SDY08520328GA SDY08520346GA SDY08520377GA SDY09020424GA SDY08500171GA SDY08500172GA SDY08500189GA SDY08500196GA SDY08500241GA SDY08510248GA SDY08510253GA SDY08500203GA SDY08500208GA SDY08480090GA SDY08490136GA SDY08490145GA SDY08490147GA SDY09010378GA SDY08510280GA SDY08520345GA SDY08500186GA SDY08490108GA SDY08490150GA SDY08500210GA SDY08500217GA SDY08500225GA SDY08500236GA SDY08510247GA SDY08510254GA SDY08510255GA SDY09050483GA SDY08500179GA SDY08520375GA SDY08500242GA SDY08480086GA SDY08480087GA SDY08490092GA SDY08490105GA SDY08490110GA SDY08490112GA SDY08490113GA SDY08490146GA SDY08500191GA SDY09010394GA SDY09030461GA SDY08480084GA SDY08480088GA SDY08490096GA SDY08490122GA SDY08500240GA SDY09030439GA SDY08510265GA SDY09020407GA SDY09020414GA SDY08500153GA SDY08510284GA SDY08520341GA SDY08520343GA SDY08490099GA SDY08490104GA SDY08490107GA SDY08490115GA SDY09030457GA SDY08500213GA SDY09030431GA SDY09030441GA SDY08490097GA SDY08490118GA SDY09010392GA SDY09010396GA SDY09010401GA SDY08510317GA SDY08520324GA SDY08520329GA SDY08520336GA SDY08520351GA SDY08520360GA SDY08500237GA SDY08510245GA SDY08510266GA SDY08510275GA SDY08510276GA SDY08510278GA SDY08510279GA SDY08510283GA SDY08510294GA SDY08510298GA SDY08520373GA SDY09030454GA SDY09030464GA SDY09030466GA SDY09050471GA SDY09050473GA SDY09050480GA SDY08490126GA SDY08500235GA SDY08510256GA SDY08510268GA SDY08510244GA SDY08510246GA SDY08510251GA SDY08510274GA SDY08510277GA SDY08510281GA SDY08510288GA SDY08510289GA SDY08510291GA SDY08510295GA SDY08510301GA SDY08510306GA SDY08510308GA SDY08510309GA SDY08510310GA SDY08510315GA SDY08490123GA SDY08520357GA SDY08500202GA SDY08500205GA SDY08510271GA SDY08510272GA SDY08500206GA SDY08500207GA SDY08500209GA SDY08500211GA SDY08500221GA SDY08500228GA SDY08500229GA SDY08500231GA SDY08490114GA SDY08490151GA SDY08500218GA SDY08500226GA SDY08500227GA SDY08500232GA SDY09010380GA SDY09050475GA SDY09050488GA SDY09050496GA SDY08490141GA SDY08500154GA SDY08500157GA SDY08500193GA SDY08500198GA SDY08500201GA SDY08510264GA SDY08510302GA SDY08500187GA SDY08490148GA SDY08510250GA SDY08510303GA SDY08510307GA SDY08510311GA SDY08520319GA SDY08520330GA SDY08520332GA SDY08520344GA SDY08520369GA SDY09050469GA SDY08490135GA SDY08490138GA SDY08490144GA SDY08500155GA SDY08500177GA SDY08500178GA SDY08500188GA SDY08500190GA SDY08510314GA SDY08520370GA SDY09010387GA SDY09020429GA SDY09030432GA SDY09030447GA SDY09030455GA SDY09050472GA SDY08490106GA SDY08490134GA SDY08490143GA SDY08500169GA SDY08500182GA SDY08500220GA SDY08500234GA SDY08490129GA SDY08510304GA SDY08500199GA SDY08500233GA SDY09020411GA SDY08500212GA SDY08500216GA SDY09050482GA SDY08520337GA SDY09050495GA SDY08500183GA SDY08500185GA SDY08510252GA SEE09040062GA and SDY08500219GA.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH REPUBLIC, GERMANY, EGYPT, SPAIN, FRANCE, GREAT BRITAIN, ITALY, POLAND and SWEDEN.
  • 제품 설명
    GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). || The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.
  • Manufacturer
    GE Medical Systems Information Tecnology

Manufacturer

GE Medical Systems Information Tecnology
  • 제조사 주소
    GE Medical Systems Information Tecnology, 9900 Inovation Drive, RP 2122 3rd Floor, Wauwatosa WI 53226
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA