MX8000 IDT MULTISLICE C+ IMAGING SYSTEM 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHILIPS ELECTRONICS LTD. 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
    41362
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-03-15
  • 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
    Philips healthcare has received a report from the field stating that when they viewed the ctdi(vol) information from the pacs system the calculations were too high. upon investigation after the image dataset was sent to the pacs system the ctdi(vol) for type 3 dicom tag 0018:9345 calculation was corrupted. instead of storing the ctdi(vol) value for each slice in the dicom tag the system took the sum of all ctdi(vol) values from all the images in the dataset and stored this value in the dicom tag.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: OFF-EI-590 (Lot serial: 3056); Model Catalog: OFF-EI-590 (Lot serial: 3279); Model Catalog: OFF-EI-590 (Lot serial: 2530); Model Catalog: OFF-EI-590 (Lot serial: 3262); Model Catalog: OFF-EI-590 (Lot serial: 3236); Model Catalog: 4535 670 73181 (Lot serial: 2591); Model Catalog: 4535 670 73191 (Lot serial: 2557); Model Catalog: 4535 670 73181 (Lot serial: 3343); Model Catalog: 4535 670 73191 (Lot serial: 3343); Model Catalog: 4535 670 73181 (Lot serial: 9746); Model Catalog: 4535 670 73191 (Lot serial: 2596); Model Catalog: 4535 670 73181 (Lot serial: 2596); Model Catalog: 4535 670 73191 (Lot serial: 2591); Model Catalog: 4535 670 73181 (Lot serial: 2557); Model Catalog: 4535 670 73191 (Lot serial: 2589); Model Catalog: 4535 670 73181 (Lot serial: 2589); Model Catalog: 4535 670 73191 (Lot serial: 9746)
  • 제품 설명
    MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Manufacturer

Manufacturer

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