Events

Device Recall Digital Radiography System with Flat Panel Detector 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Med Sys 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
    45567
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0293-2008
  • 사례 시작날짜
    2007-10-01
  • 사례 출판 날짜
    2007-11-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65789
  • 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
    Angiography System - Product Code MQB
  • 원인
    System lock-up: when performing das one shot, the system may lockup due to a software timing error.
  • 조치
    Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.

Device

Device Recall Digital Radiography System with Flat Panel Detector
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
  • 제품 설명
    Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • 제조사 주소
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA