Events

Innova 21211Q/31311Q Biplane Cardiovascular Imaging System. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    53596
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0540-2010
  • 사례 시작날짜
    2009-10-14
  • 사례 출판 날짜
    2009-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85953
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    Ge healthcare has become aware of a potential limit switch failure with innova 2121iq and 3131iq (biplane) systems that may impact patient safety. a potential limit switch failure could occur due to collision between the lateral plane of innova positioner and other equipment in the room. this collision may break the x-ray and positioning switches, and may not allow exam completion. to date, no in.
  • 조치
    GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.

Device

Innova 21211Q/31311Q Biplane Cardiovascular Imaging System.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 567819BU8 553647BU9 572635BU1 554557BU9 577013BU6 553645BU3 554559BU5 554554BU6 570810BU2 575321BU5 561974BU7 561975BU4 552392BU3 576688BU6 0CLINIC-6 566788BU6 568141BU6 576766BU0 549882BU9 561354BU2 559228BU2 569784BU2 559230BU8 559229BU0 559232BU4 558488BU3 560201BU6 553915BU0 567597BU0 570811BU0 555791BU3 555795BU4 558485BU9 561968BU9 561973BU9 549588BU2 554561BU1 558484BU2 574676BU3 560203BU2 555794BU7 556324BU2 558482BU6 565971BU9 560199BU2 560200BU8 554555BU3 575318BU1 576574BU8 00CLINIC3 556326BU7 556328BU3 555793BU9 555792BU1 558483BU4 561971BU3 558481BU8 553916BU8 570809BU4 566407BU3 567820BU6 573589BU9 553216BU3 559231BU6 553917BU6 561970BU5 561969BU7 577012BU8 561753BU5 551152BU2 549881BU1 556327BU5 00CLINIC4 CLINICAL2 554562BU9 558489BU1 553646BU1 550100BU2 573164BU1 574334BU9 554563BU7 556322BU6 561355BU9 561356BU7 569351BU0 578479BU8 554556BU1 560202BU4 554560BU3 570231BU1 551164BU7 558486BU7 556329BU1 556331BU7 558487BU5 568140BU8 566406BU5 578416BU0 558490BU9 554558BU7 556323BU4 561353BU4 576361BU0 561972BU1 552393BU1 566180BU6 561967BU1 569498BU9 556330BU9 CLINICAL 1 570095BU0 561754BU3 553918BU4 and 556325BU9.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHILE , CANADA and BAHRAIN.
  • 제품 설명
    GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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