RAPIDPOINT 500 SYSTEM - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    30913
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-09-24
  • 사례 국가
  • 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
    Users can inadvertently enter a wrong patient id on the demographics screen which ultimately could lead to a misidentification of the sample. a patient sample mismatch could be caused by: 1. inadvertently accepting the pre-selected patient id on the demographics screen 2. overwriting sample demographics by incorrect operation of the patient list button 3. scanning the wrong barcode id 4. manually typing in the wrong id in each of these cases failure to check the correct demographics screen before moving on to the results screen will assign the wrong demographics to the sample being tested.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: RAPIDPOINT 500 (Lot serial: ); Model Catalog: 10492730 (Lot serial: ); Model Catalog: 1260 (Lot serial: ); Model Catalog: RAPIDPOINT 405 (Lot serial: ); Model Catalog: 05320281 (Lot serial: ); Model Catalog: 1245 (Lot serial: ); Model Catalog: 1265 (Lot serial: ); Model Catalog: 1240 (Lot serial: ); Model Catalog: 129887 (Lot serial: ); Model Catalog: 106444 (Lot serial: ALL S/N FOR ALL DEVICES)
  • 제품 설명
    RAPIDPOINT 500 SYSTEM-MAIN UNIT
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC