Events

Innova 3100 / 3100 IQ 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
    52056
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0135-2010
  • 사례 시작날짜
    2009-04-16
  • 사례 출판 날짜
    2009-11-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82006
  • 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
    Cardiovascular Imaging System - Product Code MQB
  • 원인
    Potential pump failure associated with the coolix 4000 chiller of the innova single plane and biplane systems that may stop the chiller from working. if a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the x-ray is inhibited. this could lead to a delay in treatment and possible additional x-ray exposure and contra.
  • 조치
    Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Innova 3100 / 3100 IQ
  • 모델명 / 제조번호(시리얼번호)
    SYSTEM ID: 65049331 850060732 2538483100 4082593100 7133933100 9284533100 82416060004 0002728403 01224VAS04  082416040025 082416100008 082416120017 082416230005 202782LABB  214324INNOVA2 27305ANGI1 303629CL4 303788CL2 318254CL 325428CATH1 361857CATH1 361980INNOVA2  478274CTH1 479441CV1  4959INV31 503561CL3 512901NI3100 563421CATHLAB8 573AMC3100  600123VA02  619482INNOVA1  650369SV3 704355RM2  706774HT8  717270INNOVA31  727942CATH  732776CATH6 770HMCCL2  787844INNOVACL 803256LAB2  808485INNOVA  814231C1 815226INN2  864512CL1  864512CL2  865481CCL2  951788INNOVA2 A51273120 BPINNOVA4 BPINNOVA5  BY4067VA02 BY4069VA01 FPG30528  HU1042VA01  IL1098VA01 NPV15952  PL1008VA02 RU1295VA03 RU1295VA04 RU1453VA01 RU1618VA01 RU1999VA01  RU2076VA02 RU2741VA03 RU2747VA01  RU3260VA01  RU3290VA01 RU3304VA01  RU3317VA01 RU3328VA01 UA4230VA01 XF0158 YV0044 YV0171  YV0175  YV0180  YV0700 Z001RX07
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
  • 제품 설명
    GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • 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