Events

1.5T SIGNA INFINITY TWINSPEED WITH EXCITE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    24038
  • 사례 위험등급
    II
  • 사례 시작날짜
    2009-09-09
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Use of cadstream with "pure" software for dynamic mri imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Device

1.5T SIGNA INFINITY TWINSPEED WITH EXCITE
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: M3000TD (Lot serial: MANUFACTURER); Model Catalog: M3000TD (Lot serial: >10 NUMBERS); Model Catalog: M3000TD (Lot serial: CONTACT); Model Catalog: M3000LF (Lot serial: 274168MR4 270572MR1); Model Catalog: M7000BF (Lot serial: S/N'S 291192MR3 290992MR7); Model Catalog: M3000LF (Lot serial: S/N'S HDMR10368 7547YR3); Model Catalog: M3000LF (Lot serial: 278606MR9 266072MR8); Model Catalog: 2294302 (Lot serial: 253630MR8 239043MR3); Model Catalog: 2294302 (Lot serial: S/N'S 243409MR0 239046MR6); Model Catalog: 2294302 (Lot serial: 256216MR3 246610MR0); Model Catalog: 2294302 (Lot serial: 258415MR9 247728MR9); Model Catalog: 2294302 (Lot serial: 242181MR6); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: S/N 30BD4960); Model Catalog: M3333TA (Lot serial: S/N'S 6690YR2 266690MR7); Model Catalog: M3335PB (Lot serial: >10 NUMBERS); Model Catalog: M3335PB (Lot serial: CONTACT); Model Catalog: M3335PB (Lot serial: MANUFACTURER); Model Catalog: M3335JK (Lot serial: S/N 7555YR6)
  • 제품 설명
    1.5T SIGNA INFINITY TWINSPEED EXCITE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)