Events

INFX8000V 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Medical Systems Inc 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
    73078
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0752-2016
  • 사례 시작날짜
    2015-08-14
  • 사례 출판 날짜
    2016-02-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143016
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    When a fontal da (digital angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. as a result, the dose meter sent a minus value to the software. consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. the following message was displayed, "dose meter abnormal, dose info disabled".
  • 조치
    Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.

Device

INFX8000V
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution to OH and NY
  • 제품 설명
    INFX-8000V Bi-Plane X-Ray Interventional System || X-ray systems
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • 제조사 주소
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA