Events

LIGHTSPEED 16 CT SCANNER SYSTEM 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
    46563
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-01-26
  • 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
    Gehc has updated the service manuals used to maintain these scanners to fix an incorrect torque value which is the source of the field action. fmi 25463 identified a torque issue with 5 volt supplies in ct and pet lightspeed systems and corrected the issue by field action as well as a technical manual update. this recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.

Device

LIGHTSPEED 16 CT SCANNER SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: B7868JA (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S9118JS (Lot serial: 00000348810CN3); Model Catalog: S9118JS (Lot serial: 00000349405CN1)
  • 제품 설명
    LIGHTSPEED 16 CT SCANNER SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)