Events

InstaTrak with Multiple Dataset Navigation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE OEC Medical Systems, Inc 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
    62112
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1985-2012
  • 사례 시작날짜
    2006-09-15
  • 사례 출판 날짜
    2012-07-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109866
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being classified by the agency. on october 11, 2006, ge healthcare recalled ge oec instatrak 3500 plus system with software version 5.2, the surgical navigation and visualization application due to software related issues.
  • 조치
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caution when using the affected product until the 5.2.1software upgrade is completed. For question contact GE Healthcare Customer Service at 1-800-874-7378, option 1 or 1-801-536-4688, option 1. For questions regarding this recall call 801-536-4516.

Device

InstaTrak with Multiple Dataset Navigation
  • 모델명 / 제조번호(시리얼번호)
    IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-RC, IT35148, IT35150, IT35153P, IT35156, IT35161, IT35162P-RC, IT35164, IT35169P-RC, IT35170G-RC, IT35175, IT35182G-RC, IT35183P-RC, IT35186P, IT35187P, IT35189P, IT35192P, IT35193P, IT35194P, IT35195P, IT35200P, IT35201P, IT35207P, IT35208P, IT35209P, IT35211P-RC, IT35214P, IT35215P, IT35220P, IT35222P, IT35223P, IT35225P, IT35228P, IT35231P, IT35232P, IT35234P, IT35236P, IT35237P, IT35240P, IT35242P, IT35245P, IT35248P, IT35251P, IT35252P, IT35253P, IT35263P, IT35265P, IT35269P, IT35270P, IT35271P, IT35273P, IT35274P, IT35277P, IT35280P, IT35284P, IT35285P, IT35290P, IT35293P, IT35294P, IT35295P, IT35296G, IT35297P, IT35299P, IT35300P, IT35302P, IT35303P, IT35304P, IT35309G, IT35310P, IT35311P, IT35312P, IT35315P, IT35316P, IT35322P, IT35323P, IT35324P, IT35330P, IT35331P, IT35334P, IT35341G, IT35342G, IT35344, IT35348P, IT35350P, IT35351P, IT35352P, IT35360P, IT35364P-RC, IT35365P, IT35367P, IT35372P, IT35377P, IT35380P, IT35383P.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide)
  • 제품 설명
    InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. || Product Usage: Usage: || The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA