Infinia nuclear medicine systems; VG and VG Hawkeye nuclear medicine systems; Helix nuclear medicine systems; Brivo NM615; Discovery NM630; Optima NM/CT640; and Discovery NM/CT 670 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Healthcare 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
  • 날짜
    2013-07-05
  • 사례 출판 날짜
    2013-07-05
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: ge healthcare nuclear medicine systems it has come to our attention that medical device manufacturer, ge healthcare has initiated a field safety corrective action concerning its nuclear medicine systems. the affected products are 1) infinia nuclear medicine systems; 2) vg and vg hawkeye nuclear medicine systems; 3) helix nuclear medicine systems; 4) brivo nm615; 5) discovery nm630; 6) optima nm/ct640; and 7) discovery nm/ct 670. on 5 june 2013, ge healthcare became aware of an incident in the united states that a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. investigation by the manufacturer found that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. because of the similarities in the design of support mechanisms across many products, the manufacturer has included all types and manufacturing dates of infinia and infinia hawkeye nuclear medicine systems; all types and manufacturing dates of vg and vg hawkeye nuclear medicine systems; and all types and manufacturing dates of helix nuclear medicine systems by elscint ltd. the manufacturer stated that the issue should also affected brivo nm615, discovery nm630, optima nm/ct640, discovery nm/ct670 due to similarities in basic mechanical concepts between these devices and the infinia systems. ge healthcare will inspect all affected systems to verify that the support mechanism fasteners are secured properly. furthermore, ge healthcare recommends that users to cease use of their nuclear medicine system until ge healthcare can complete an inspection of their system. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 july 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Medical Device Safety Alert: GE Healthcare nuclear medicine systems
  • Manufacturer

Manufacturer