Events

Device Recall OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P 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
    62715
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2251-2012
  • 사례 시작날짜
    2009-06-22
  • 사례 출판 날짜
    2012-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111483
  • 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
    Ge healthcare surgery had discovered that using the inverted headset placement is not a validated configuration with the it 3000, 2500, 2500 plus, 3500, 3500 plus, connectstat, and connectstat plus surgical navigation equipment.
  • 조치
    GE Healthcare sent an Urgent Safety Advisory Notice dated June 22, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised not to use the ENT registration Headset in the inverted position for any CT scans or surgical procedures and to remove all references in their Naviation System Operator's Manual that discuss an inverted headset placement, and replace it with the enclosed updated instructions for the Navigation System Operator's Manual. For any questions customers should contact the service team for further information at 800-874-7378, option #8. For questions regarding this recall call 801-536-4516.

Device

Device Recall OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500...
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.
  • 제품 설명
    OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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, MRI, 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