Events

Device Recall OEC 9900 Elite 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
    67867
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1462-2014
  • 사례 시작날짜
    2014-03-31
  • 사례 출판 날짜
    2014-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126531
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    Ge healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain oec 9900 systems, causing the spring arm and monitor to fall forward.
  • 조치
    GE Healthcare sent an Urgent Medical Device Correction letter dated March 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use caution when positioning or extending the workstation articulating arm. In addition, refrain from positioning staff or patients directly underneath or in front of a workstation monitor. Your local GE Healthcare Field Engineer will contact you to coordinate the replacement of the screws, and ensure that your system is operating safely and meets all specifications. These activities will be performed at no cost to you. Should you have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately. UPDATE: On June 20, 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction Letter to customers with affected units. The letter makes clear that this field correction applies to all user sites with the listed products, regardless of whether service work was performed on the monitor extension arm since 3/31/2014.

Device

Device Recall OEC 9900 Elite
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers - OEC 9900 Elite
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
  • 제품 설명
    The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. || Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA