Product: INFINIA - Registration: 80071260049 - Risk Class III - High Risk - Technical Name: Nuclear Imaging System - Model: GE Healthcare Systems Infinia and Infinia Hawkeye Nuclear Medicine, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine, all the settings (SEE APPENDIX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE MEDICAL SYSTEMS, F.I. HALFA D/B/A ELGEMS LTDA. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1458
  • 날짜
    2014-10-09
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    GE Healthcare "recommends that users monitor patients and systems throughout the scanning procedure to ensure there is sufficient space between the patient and the detectors. If the detector comes into contact with the patient, the user must press the Detector Out button on the Remote Control Unit to reverse the movement of the detector. If any unintended movement of the detector is identified, the user must press the Emergency Off button on the console or gantry to stop this movement and pull the patient release handle to remove it as indicated in the manual of user. When using Pressure Sensitive Devices in the gantry, this may not stop unintended movement of the detector. If you see error # 147 on axis 1, it will need to follow the instructions in the user manual and contact GE Services. "(LETTER TO CUSTOMERS IN ANNEX)
  • 원인
    According to the company, "during a whole body scan, the detector can move into the initial position and then slowly initiating the internal movement toward the patient. this move will generate both a visual and audio alert condition on the console and the gantry. this mode of failure was observed in a single system. ".
  • 조치
    Company will perform Update, correction or complementation of the instructions for use - Software update - IMF Code 40856